CLINICAL TRIAL

Signatera ctDNA assay for Colorectal Cancer

Grade I
Metastatic
Refractory
Recruiting · 18+ · All Sexes · Gainesville, FL

This study is evaluating whether a new test may help doctors determine the best treatment for patients with colorectal cancer.

See full description

About the trial for Colorectal Cancer

Eligible Conditions
Metastatic Colorectal Cancer (CRC) · Colorectal Neoplasms

Treatment Groups

This trial involves 2 different treatments. Signatera CtDNA Assay is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
pre-specified sequence of FDA-approved drugs and drug combinations
DRUG
Signatera ctDNA assay
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
pre-specified sequence of FDA-approved drugs and drug combinations
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects must have tissue from either the primary and/or metastatic deposit available for submission at enrollment. Tissue can be from either a biopsy or resection surgery, whichever is most recent, but must be from the past five years.
Histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease measurable by RECIST v1.1 and not currently a candidate for oligometastatic definitive management
Must have progressed or have demonstrated intolerance to first line therapy for metastatic disease. Individuals who recurred within 6 months of completion of oxaliplatin based adjuvant chemotherapy are also eligible.
Subjects must have tissue and blood shipped to Natera no fewer than 10 business days prior to starting treatment.
Subjects must have had molecular profiling to determine tumor RAS, BRAF and MMR/MSI status
Subjects with known or suspected Gilbert's disease must be formally tested for UGT1A1*28 with results available to study team prior to treatment initiation
Any clinically relevant (as deemed by the PI) adverse events related to prior therapies must have resolved to Grade 1 or less (CTCAE 5.0) at study enrollment
Age ≥18 years
ECOG performance status of 0-2
Life expectancy of at least 6 months
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Signatera ctDNA assay will improve 1 primary outcome and 2 secondary outcomes in patients with Colorectal Cancer. Measurement will happen over the course of 1 year.

Overall survival
1 YEAR
Compare the overall survival in subjects who receive ctDNA assay-guided treatment and scan-guided treatment
1 YEAR
Progression free survival
1 YEAR
Compare the progression free survival in subjects who receive ctDNA assay-guided treatment and scan-guided treatment
1 YEAR
Best overall response
1 YEAR
Compare the proportion of subjects having each category of response during study participation (complete response, partial response, stable disease, and progressive disease) per RECIST v1.1 criteria
1 YEAR

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can colorectal cancer be cured?

In an era in which cancer therapy is advancing with faster and better response rates, a cure isn’t realistic. The goal of treatment is PFS (Percivallate for the treatment of patients who have answer: An increasing proportion of patients are being diagnosed with metastatic disease. The median survival in those with only one extrapulmonary metastasis has been improved markedly in recent years, possibly owing to a decline in hepatic and pulmonary metastatic disease. Although prognosis remains poor, a longer survival from diagnosis of metastatic disease than from diagnosis of M1 disease is being observed in current series, but this cannot be attributed to PFS differences between those with 1 and 2 metastatic sites.

Anonymous Patient Answer

How many people get colorectal cancer a year in the United States?

Nearly 1 in 6 are newly diagnosed with colorectal cancer each year. Older persons more often have localized disease and are candidates for curative treatment, while younger persons are often diagnosed with advanced disease that cannot be managed by surgery or radiation therapy.

Anonymous Patient Answer

What are common treatments for colorectal cancer?

Because of the complex nature of the tumors on which our cancer doctors must practice, they commonly refer patients to oncologists for the purpose of therapy. Although surgical therapy is the traditional treatment modality, it contributes only a small portion to cure, whereas the more conventional cancer treatments of chemotherapy and radiation therapy are much more effective. Even surgery, such as for colorectal cancer, will confer survival benefits for some patients. It is important for a colorectal oncologist to be aware of the potential for improved survival, even regardless of optimal treatment, when the patient is receiving appropriate chemotherapy and/or radiation therapy.

Anonymous Patient Answer

What are the signs of colorectal cancer?

Symptoms in patients with colon cancer include malaise, weight loss, loss of appetite, anemia, and bowel obstruction, with the last two commonly appearing in stage III disease. Most patients with stage II disease do not present with any of the symptoms. Tumour markers and sigmoidoscopy will also increase the likelihood of finding the disease beyond stage II.

Anonymous Patient Answer

What is colorectal cancer?

In the UK, [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) is thought to account for roughly 1,500 new cases every year and 6,500 deaths every year. It was the third most common cause of cancer death in 2012/13 in the UK. It starts in the colon, which lies just underneath the layers of skin and fat that cover most of the inner surface of the abdomen. It is caused by either genetic mutations, environmental pollutants or a combination of both. It can be easily caught and stopped. Cancer is divided into different types based on the way in which cancer spreads and if it can be cured or not. The four most common types are colorectal cancer, skin cancer, throat cancer and stomach cancer.

Anonymous Patient Answer

What causes colorectal cancer?

There is a clear case for a hereditary component to colorectal cancer. On the basis of evidence from several large, population-based case-control studies, a hereditary component to colorectal cancer has been confirmed. The strongest evidence for a familial component comes from the observation of a peak among patients who developed colorectal cancer during adulthood.\n

Anonymous Patient Answer

Have there been other clinical trials involving signatera ctdna assay?

In a recent study, findings from this study have implications for the current use of the stool-based test. If validated, this assay would make a significant contribution to the clinical management of CRC.

Anonymous Patient Answer

What are the chances of developing colorectal cancer?

Even at a young age, many factors can affect the risk of CRC and colon cancer, as shown in the table above. Colonoscopies are the standard of care and offer a high detection rate, but it is important to recognize the possible underlying risk factors present in the patient before and after the screening procedure. It is extremely important to understand the factors influencing the risk of CRC in order to prevent it from occurring in the first place. When CRC does occur, it is critical for patients to receive optimal care and have their risk-factor checked appropriately – since in the United States, an estimated 1 and 2,000 patients are diagnosed with CRC and colon cancer every year.

Anonymous Patient Answer

What is the survival rate for colorectal cancer?

After resection, colorectal cancer patients had a 5-year survival rate of about 58%, a 3-year survival rate of about 41% and a 2-year survival rate of about 35%. Survival of patients with stage II tumors were significantly better than patients with stage III or IV tumors. Survival rates were also significantly better among older patients compared to older patients under the age of 50 years.

Anonymous Patient Answer

What is the latest research for colorectal cancer?

The latest research does not indicate the likelihood of any improvements in the management of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) and treatment efficacy. In fact, recent advances suggest that colorectal cancer in its most advanced stages may be associated with a decline in survival; in all cases of colorectal cancer, the five-year survival rate remains stable. The average survival at the end of the 20th century is still less than five months (and for Stage II colon cancer, less than a year) and colorectal cancer is the second leading cause of cancer mortality in the Western world. The survival of the cancer patient is further adversely affected by the delays in diagnosis of colorectal cancer and treatment.

Anonymous Patient Answer

Is signatera ctdna assay safe for people?

The study suggests that, following a standard protocol, signatera ctdna assay for fecal testing is safe to use to screen colonoscopy outpatients. When indicated by their screening protocol, these patients may not be exposed to overtreatment by a negative test-result.

Anonymous Patient Answer

Has signatera ctdna assay proven to be more effective than a placebo?

All of our results are preliminary and need verification. The primary endpoint of this study was change in rectal mucosal DNA % change after treatment. This was calculated as the change in % of tumor cells compared to the baseline % after treatment and divided by the pre-treatment %. In all of the groups, the % change in cells was statistically statistically significantly increased (p<0.05) from baseline. Our trial shows that with Signotera the results are statistically significant.

Anonymous Patient Answer
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