Signatera Test Came out positive

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jumpman50512
Posts: 32
Joined: Thu Jan 10, 2019 10:36 pm

Signatera Test Came out positive

Postby jumpman50512 » Thu May 27, 2021 6:16 pm

hello everyone

I hope you guys are doing great. Well, i just went to the doctor for the regular check-up and he did the signatera test and well it came out positive. Dang that sucked. Anyways another ct scan in 3 weeks. And my cea went high to 13 now. Pretty sure he's looking for something now. Just wondering has anyone had a reoccurrence removed without any chemo? I am scared of more chemo I remember it being so hard those final rounds.

thanks
Stage IV Survivor Currently (Diagnosed @ 29) currently 33
1 Met to the Liver
Colo-Rectal cancer surgery
12 rounds of chemo + Radiation + Oral Chemo
12/1/21 Colonoscopy Clean
2/1/21 CT scan Clean
2/1/21 CEA at 5.8
4/1/21 CEA currently at 8.8
5/27/21 CEA currently at 13
Signatera Positive :cry:
Clean CT Scan 4/15/21
It's back :cry: 6/24/21

Vana3
Posts: 49
Joined: Tue Aug 13, 2019 11:40 am
Facebook Username: ma

Re: Signatera Test Came out positive

Postby Vana3 » Fri May 28, 2021 12:43 am

I am sorry to hear that it was positive. If it were me I would be demanding a PET scan
Good luck, may they not find anything!
Dx 36 yr, F, 7/19
T4aN2M1 Cea 5.1
5 cm tumor in cecum removed, 17 out of 45 LN
1 cm omental deposit removed
LVI +
Cea post surgery 4.2
MSS, KRAS g12d, Braf WT
MT: 10.9
8/20/19 MRI & PET small liver spots
9/19 - 3/20 FOLFOX
1/02/20 CEA 3.6, 2/15- 4.4 3/15- 4.6, 6/05 4.6
Liver resection 4/15/20
6/20 Ct scan clear
7/20 Cea 8.6
8/20 Cea 12.4, suspicious ovarian cyst
9/20 Hysterectomy SOB (Ovaries and uterus positive for CRC)
post surgery cea 2.6
11/20 clear scans
2/20 clear scans

I_will_fight
Posts: 81
Joined: Mon Jun 29, 2020 3:38 pm

Re: Signatera Test Came out positive

Postby I_will_fight » Fri May 28, 2021 4:08 am

jumpman50512 wrote:hello everyone

I hope you guys are doing great. Well, i just went to the doctor for the regular check-up and he did the signatera test and well it came out positive. Dang that sucked. Anyways another ct scan in 3 weeks. And my cea went high to 13 now. Pretty sure he's looking for something now. Just wondering has anyone had a reoccurrence removed without any chemo? I am scared of more chemo I remember it being so hard those final rounds.

thanks



Sorry to hear about the ctDNA result. It must be stressful to know there is "something, somewhere" and not to be able to take it out. Looking at the plus side, it should give you extra time to catch it.

Looking at your sinature I see you took oral chemo, so I presume presume you had XELODA with no Oxaliplatin. Is this correct ? Which regime did you have before radiation? Which one did you find so hard?

Maybe they can offer you a different chemo which might not be so hard on you.

Also no indication of MSI/MSS status, I am mentioning this because I understand Xeloda on its own is not very useful for MSIs.

Liver is the main metastasic site, maybe you could request a hepatic MRI?

I hope your onc can offer you a good solution.

Best regards

Javi
46 yo male Spain
06/20 - 6cm T3N0M0 CC splenic flex
No liver mets, 3 and 4 mm lung dots (unlikely to be mets)
lymp 0/37
MSH6- other MMR+
KRAS mt G13D
V/LNI absent
PNI present
07/20 - hemicol surg, 13cm clear margins, optimistic surgn.
08/20 - CAPOX regime, 4 cycles.
11/20 - CAPOX completed. CAT scan: lesion in liver, suspect hemoangioma, no changes lung dots.
12/20 - Clean colonoscopy
02/21 - MRI liver lesion is nonspecific, stable.

jumpman50512
Posts: 32
Joined: Thu Jan 10, 2019 10:36 pm

Re: Signatera Test Came out positive

Postby jumpman50512 » Fri May 28, 2021 10:05 am

thank you for the reply well it was the last rounds they gave me IV chemo and oral pills at the same time it was so hard it was double chemo but ill do what needs to be done just a little bummed but im going to enjoy these three weeks and relax i have a pet scan in 3 weeks again now so we will see what shows up on this one
Stage IV Survivor Currently (Diagnosed @ 29) currently 33
1 Met to the Liver
Colo-Rectal cancer surgery
12 rounds of chemo + Radiation + Oral Chemo
12/1/21 Colonoscopy Clean
2/1/21 CT scan Clean
2/1/21 CEA at 5.8
4/1/21 CEA currently at 8.8
5/27/21 CEA currently at 13
Signatera Positive :cry:
Clean CT Scan 4/15/21
It's back :cry: 6/24/21

boxhill
Posts: 730
Joined: Fri Apr 06, 2018 11:40 am

Re: Signatera Test Came out positive

Postby boxhill » Fri May 28, 2021 12:06 pm

If they are looking for liver masses an MRI is the scan of choice. Unfortunately, as my oncologist told be, they often have to "build a case" to get one approved by the insurance company. Your doctor will probably doing that with signatera + CTs + rising CEA. (Mine cited rising CEA even though there's never been any evidence that CEA is a marker for me. :) )
F, 64 at DX CRC Stage IV
3/17/18 blockage, r hemi
11 of 25 LN,5 mesentery nodes
5mm liver met
pT3 pN2b pM1
BRAF wild, KRAS G12D
dMMR, MSI-H
5/18 FOLFOX
7/18 and 11/18 CT NED
12/18 MRI 5mm liver mass, 2 LNs in porta hepatis
12/31/18 Keytruda
6/19 Multiphasic CT LNs normal, Liver stable
6/28/19 Pause Key, predisone for joint pain
7/31/19 Restart Key
9/19 CT stable
Pain: all fails but Celebrex
12/23/19 CT stable
5/19 MRI stable/NED
Stop Key
All MRIs NED

I_will_fight
Posts: 81
Joined: Mon Jun 29, 2020 3:38 pm

Re: Signatera Test Came out positive

Postby I_will_fight » Wed Jun 02, 2021 4:24 pm

boxhill wrote:If they are looking for liver masses an MRI is the scan of choice. Unfortunately, as my oncologist told be, they often have to "build a case" to get one approved by the insurance company. Your doctor will probably doing that with signatera + CTs + rising CEA. (Mine cited rising CEA even though there's never been any evidence that CEA is a marker for me. :) )


Just curious, how much can a MRI cost in the US?

I have paid for a couple of them out of pocket (for some other issues) and they were in the range of 250 USD, admittedly I did not use contrast, which should increase the price, but this is a test that can provide doctors with crucial data to make a decision.

Is it any more expensive than a CT Scan? I doubt it. Why do insurance companies object to authorizing MRIs?
46 yo male Spain
06/20 - 6cm T3N0M0 CC splenic flex
No liver mets, 3 and 4 mm lung dots (unlikely to be mets)
lymp 0/37
MSH6- other MMR+
KRAS mt G13D
V/LNI absent
PNI present
07/20 - hemicol surg, 13cm clear margins, optimistic surgn.
08/20 - CAPOX regime, 4 cycles.
11/20 - CAPOX completed. CAT scan: lesion in liver, suspect hemoangioma, no changes lung dots.
12/20 - Clean colonoscopy
02/21 - MRI liver lesion is nonspecific, stable.

crikklekay
Posts: 132
Joined: Thu Feb 15, 2018 9:47 am
Location: Richmond, VA

Re: Signatera Test Came out positive

Postby crikklekay » Thu Jun 03, 2021 9:47 am

Your 2021 path mirrors my husband's a lot. His oncologist went from a CT scan to a PET scan because even though the CT was clear his CEA jumped up again. We haven't done a signatera test, I only heard about it recently when it was mentioned to me that he should ask for one. The PET scan did find a spot on the liver so he then got an MRI, but it also thankfully showed nothing else significant. I've found the waiting to be the most difficult thing, there are weeks between each test and it takes a week for the doctor to see us with the results and it seems agonizingly slow. Now we're waiting on an appointment for a biopsy, they're supposed to call sometime this week but nothing yet :cry: John seems calm about possibly going into more chemo, but it has me shaking. He had a bad time of it too, especially in those last few months. You're not alone, love and good wishes for you <3

I_will_fight wrote:Just curious, how much can a MRI cost in the US?

I have paid for a couple of them out of pocket (for some other issues) and they were in the range of 250 USD, admittedly I did not use contrast, which should increase the price, but this is a test that can provide doctors with crucial data to make a decision.

Is it any more expensive than a CT Scan? I doubt it. Why do insurance companies object to authorizing MRIs?


We haven't seen the bill for his MRI yet, so I'm not sure if it's more than a CT scan but it's definitely more than $250 USD without insurance. Without insurance using an imaging center and not in a hospital, John's CT scans are about $1,500 (we pay $300 with insurance). The ones he got in the hospital were $10,000 without insurance, with insurance the cost for us was $0 because we hit our $5,000 max out of pocket that year. Our system is stupidly expensive. Insurance companies hate spending money because they are a for-profit business, so being denied a claim is always a concern. John had to have his oncologist fight with the insurance company before on his behalf to get something approved when it was originally denied.
Caring for DH John
Stage IIIC, Lymph nodes: 6/22
Chemo: FOLFOX (6)
12/17 ER and emergency surgery
02/18 Hospital w/MSSA infected port, PICC line inserted, chest CT scan showed septic emboli & blood clots
03/18 Hospital w/CDIFF
04/18 Chest CT scan clear
06/18 Colonoscopy Clear
08/18 CT Scan Clear, NEMD
2019/2021 Colonoscopy Clear
2019/2020/2021 CT Scan Clear
2021 PET scan shows activity on liver
2021 MRI confirms one spot on liver

I_will_fight
Posts: 81
Joined: Mon Jun 29, 2020 3:38 pm

Re: Signatera Test Came out positive

Postby I_will_fight » Fri Jun 04, 2021 1:00 am

crikklekay wrote:We haven't seen the bill for his MRI yet, so I'm not sure if it's more than a CT scan but it's definitely more than $250 USD without insurance. Without insurance using an imaging center and not in a hospital, John's CT scans are about $1,500 (we pay $300 with insurance). The ones he got in the hospital were $10,000 without insurance, with insurance the cost for us was $0 because we hit our $5,000 max out of pocket that year. Our system is stupidly expensive. Insurance companies hate spending money because they are a for-profit business, so being denied a claim is always a concern. John had to have his oncologist fight with the insurance company before on his behalf to get something approved when it was originally denied.


Oh, this is wildly different from my country. I guess having to compete with a free social security drives the costs down in Spain.
46 yo male Spain
06/20 - 6cm T3N0M0 CC splenic flex
No liver mets, 3 and 4 mm lung dots (unlikely to be mets)
lymp 0/37
MSH6- other MMR+
KRAS mt G13D
V/LNI absent
PNI present
07/20 - hemicol surg, 13cm clear margins, optimistic surgn.
08/20 - CAPOX regime, 4 cycles.
11/20 - CAPOX completed. CAT scan: lesion in liver, suspect hemoangioma, no changes lung dots.
12/20 - Clean colonoscopy
02/21 - MRI liver lesion is nonspecific, stable.

crikklekay
Posts: 132
Joined: Thu Feb 15, 2018 9:47 am
Location: Richmond, VA

Re: Signatera Test Came out positive

Postby crikklekay » Fri Jun 11, 2021 11:36 pm

I_will_fight wrote:
Oh, this is wildly different from my country. I guess having to compete with a free social security drives the costs down in Spain.


I just got the bill for the MRI, it was $8,146.68 without insurance and $100 with my insurance. I also got the bill for his PET scan, which was denied and over $10,000. I now have to appeal and fight to get it covered because they claim it isn't "covered by our health plan" and I definitely don't have $10K USD to pay it out of pocket. uugggghhh
Caring for DH John
Stage IIIC, Lymph nodes: 6/22
Chemo: FOLFOX (6)
12/17 ER and emergency surgery
02/18 Hospital w/MSSA infected port, PICC line inserted, chest CT scan showed septic emboli & blood clots
03/18 Hospital w/CDIFF
04/18 Chest CT scan clear
06/18 Colonoscopy Clear
08/18 CT Scan Clear, NEMD
2019/2021 Colonoscopy Clear
2019/2020/2021 CT Scan Clear
2021 PET scan shows activity on liver
2021 MRI confirms one spot on liver

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beach sunrise
Posts: 499
Joined: Thu Mar 05, 2020 7:14 pm

Re: Signatera Test Came out positive

Postby beach sunrise » Sat Jun 12, 2021 1:07 am

Any extra information besides Signatera test was positive? Did you learn anything else?
I will be having the test on Thursday.
8/19 RC CEA 82.6 T3N0M0
Neoadj 5FU/rad 6 wk
High dose IVC 1 1/2 wks before surgery. Continue still twice a week
Surg 1/20 APR - margins T4bN1a IIIC G2 MSI- 1/20 LN+ LVI+ PNI-
pre cea 24/post 5.9
FOLFOX
7 rds 6-10 CEA 11.4 No more
7/20 CEA 11.1, 8.8
8/20 CEA 7.8
9/20 CEA 8.8, 9, 8.6
10/20 CEA 8.1
11/20 CEA 8's
12/20 CEA 8's & 9's
ADAPT+++ TM drug
MHL1+
PMS2+
MSH2+
MSH6+
POLD1 , KRAS Q61H
Chem-sens test NCI "Test failed, neo adj CR worked. Not enough ca cells to test"

User avatar
Green Tea
Posts: 421
Joined: Mon Oct 24, 2016 10:48 am

Re: Signatera Test Came out positive

Postby Green Tea » Sat Jun 12, 2021 12:29 pm

beach sunrise wrote:Any extra information besides Signatera test was positive? Did you learn anything else?
I will be having the test on Thursday.

It would be interesting to know just what kinds of specific data items the test report contains. It would be nice to be told which specific 16 DNA mutations your customized assays were based on. In addition, it would be nice to have a quantitative measure in addition to a simple "positive" vs. "negative" result so that if subsequent tests are also found to be positive you could tell if the concentration is going up, going down or remaining stable.

I looked through the website for Signatera, but I couldn't find any explicit indication of what, exactly, the report contains. It looks like it at least contains a two-level distinction between "ctDNA High Risk" and "ctDNA Low Risk" (which is basically the distinction between "positive" and "negative" relative to a pre-defined cut-off level). But I don't know if the report contains any sort of quantitative measure, such as "concentration of ctDNA per cubic nanometer of serum" or whatever measure they are using to determine level of "Molecular Residual Disease (MRD)"

It is my understanding that the way the testing procedure works is that they first test your tumor-tissue sample as well as your normal-tissue sample against a database of 440 likely DNA mutations to find a subset of 16 mutations that are highly expressed in your tumor-tissue sample but not present at all in your normal-tissue sample. Then they design a custom-made assay that will test for the presence of these 16 DNA mutations in your blood. Each time you send in a blood sample they will then run your customized 16-mutation assay against your blood sample to see if they find a significant level of these 16 mutations.

This is described briefly at various places on the website, e.g.:


I wish that they were a little more transparent in describing what exactly they are doing and what exactly the patient will get as output in the report. Maybe someone who has already received a ctDNA report can reply and indicate what's in their report.

Also, I wish they had more documentation written at a level that a genetics-naive reader could understand. Earlier I tried to learn a few things about genetics and genomics but even the Genetics for Dummies Cheat Sheet was too difficult for me to understand.
Last edited by Green Tea on Sat Jun 12, 2021 6:03 pm, edited 1 time in total.

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beach sunrise
Posts: 499
Joined: Thu Mar 05, 2020 7:14 pm

Re: Signatera Test Came out positive

Postby beach sunrise » Sat Jun 12, 2021 1:13 pm

Hi Green Tea, how you described it was how they basiclly explained the test to me. Instead of testing the tumor removed at surgery they will be testing the initial biopsied because it is not damaged by neo-adjuvant tx. They are suppose to send me a more detailed (technical) explanation of how it works and the beneficial info they will gain from it. If I do not receive it by Tues I will be calling because I want to know before blood draw on Thursday. I will post the info they send me on the details.
The NEO Genomics test only showed I had kRAS Q61H
The Myraid myVision done with gyn showed POLD1 variant with uncertain clinical significance
So, if this Signatera test can show more with detailed explanation it will be worth it
I have had two different test looking for CTC's, one said 2 cells per 7.5ml, the other showed 4 cells per. Idk, it will be very interesting for sure.
8/19 RC CEA 82.6 T3N0M0
Neoadj 5FU/rad 6 wk
High dose IVC 1 1/2 wks before surgery. Continue still twice a week
Surg 1/20 APR - margins T4bN1a IIIC G2 MSI- 1/20 LN+ LVI+ PNI-
pre cea 24/post 5.9
FOLFOX
7 rds 6-10 CEA 11.4 No more
7/20 CEA 11.1, 8.8
8/20 CEA 7.8
9/20 CEA 8.8, 9, 8.6
10/20 CEA 8.1
11/20 CEA 8's
12/20 CEA 8's & 9's
ADAPT+++ TM drug
MHL1+
PMS2+
MSH2+
MSH6+
POLD1 , KRAS Q61H
Chem-sens test NCI "Test failed, neo adj CR worked. Not enough ca cells to test"

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beach sunrise
Posts: 499
Joined: Thu Mar 05, 2020 7:14 pm

Re: Signatera Test Came out positive

Postby beach sunrise » Wed Jun 16, 2021 11:33 am

Signatera update: Rep called instead of putting it in email. She has no idea if all 440 mutations will be listed from #1 to 440. I requested I want the FULL report, do not hold the info of all 440 results from me. The others might be important now also. She said she would find out if all are listed or just the top 16. Mhmm. She thinks for the blood test that its just a graph revealing positive or negative. Not sure if records # of cells per mLs. The reasoning is really at this point from her is finding a treatment plan or clinical trial based on results. If the whole report is not provided (withheld) I will not be doing another test. For me, it will not be worth the min data. JMO
8/19 RC CEA 82.6 T3N0M0
Neoadj 5FU/rad 6 wk
High dose IVC 1 1/2 wks before surgery. Continue still twice a week
Surg 1/20 APR - margins T4bN1a IIIC G2 MSI- 1/20 LN+ LVI+ PNI-
pre cea 24/post 5.9
FOLFOX
7 rds 6-10 CEA 11.4 No more
7/20 CEA 11.1, 8.8
8/20 CEA 7.8
9/20 CEA 8.8, 9, 8.6
10/20 CEA 8.1
11/20 CEA 8's
12/20 CEA 8's & 9's
ADAPT+++ TM drug
MHL1+
PMS2+
MSH2+
MSH6+
POLD1 , KRAS Q61H
Chem-sens test NCI "Test failed, neo adj CR worked. Not enough ca cells to test"

Brearmstrong
Posts: 108
Joined: Sun Mar 26, 2017 3:24 pm
Location: CT

Re: Signatera Test Came out positive

Postby Brearmstrong » Wed Jun 16, 2021 3:40 pm

I have had two signatera test. My understanding is that a profile of your initial tumor is created from original tissue. Then blood is drawn in present time and it compares it to your original profile. It does not note mutations or changes in genetic profile but only reports out positive or negative. If positive then it notes the level in mean tumor molecules per ml of plasma. Hope that helps.

Brenda
48 F Jan 17 2 sons
tumor appendix/colon
Muc Adeno 4cm
mod diff G2 T4aN2
nodes 8/50
CEA 4.6 after surgery <.05
KRAS G12D MSS
FOLFOX Apr-sep 17
Clean CT Jul 2017, oct 17, CEA 3.4, 8.1. May 18 2.3,1.0,1.3, 1.3, 1.0, 2.3, 2.2, 2.1,2.2,1.6,1.4,1.5,2.8,2.2
Oct 2017 clean CT
Nov 17 PET para aortic nodes Stage IV
Folfori w/avastin Dec 17
May 18- surgery on nodes xeloda continues
Aug 18-CT NED Clear CT's Nov 18-May 20
July 20 hysterectomy CEA 1.7 chemo break
July 21 vats right lung

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ginabeewell
Posts: 506
Joined: Wed Oct 24, 2018 10:30 am

Re: Signatera Test Came out positive

Postby ginabeewell » Wed Jun 16, 2021 6:58 pm

Brearmstrong wrote:I have had two signatera test. My understanding is that a profile of your initial tumor is created from original tissue. Then blood is drawn in present time and it compares it to your original profile. It does not note mutations or changes in genetic profile but only reports out positive or negative. If positive then it notes the level in mean tumor molecules per ml of plasma. Hope that helps.

Brenda


I am so curious how oncologists are using this test. I asked about it, and they said less relevant for me as my CEA is very sensitive. But am I reaching too far to say that if I just had clean scans and a negative signatera test, that might be enough to decide not to do more chemo at this juncture? Or what would it tell me?
45 YO mom of twins (9) and lucky stepmom of 14/17 year olds
9/17/18 DX stage 4 CRC w inoperable liver mets CEA 931
10/18 FOLFOX + Vectibix
12/18 typhlitis (7 days in hospital) but largest met down to 5 cm.
12/18 CEA 4.6
1/18 Resume chemo (#6-8)
3/19 HAI pump placement / colon resection
4/19 Resume chemo (#9-19) FOLFOX (no OX) + Vectibix
5/19 CEA 1.3
7/19 liver resection
10/19 liver resection
1/20 NED! CEA 0.6
3/20 two new liver mets; FOLFIRI (5) and then add Vectibix (5)
8/20 CEA 0.7
Resection next?


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