Circulating Tumor DNA for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Arvind Dasari

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active malignancies, Severe concurrent disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if certain blood markers, such as tumor DNA fragments, can predict the recurrence or spread of colorectal cancer. People with colorectal cancer often have tumor DNA circulating in their blood, and studying this could provide doctors with insights into the cancer's future behavior. Suitable participants should have a diagnosis of colorectal adenocarcinoma and be willing to provide blood samples. The study will use Minimal Residual Disease Assessment to detect small amounts of cancer cells remaining after treatment. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the Minimal Residual Disease Assessment (MRD) for colorectal cancer because it offers a more precise way to detect lingering cancer cells after treatment. Unlike standard methods, which often rely on imaging and pathology, MRD uses blood and tissue samples to identify microscopic cancer traces that might be missed. This approach can help tailor treatment plans more effectively, potentially catching recurrences earlier and improving long-term outcomes for patients.

Who Is on the Research Team?

Arvind Dasari

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Histological/cytological confirmation of colorectal adenocarcinoma.

Patients with any stage colorectal adenocarcinoma deemed potentially eligible for curative intent treatment. Patients with stages II-IV colorectal cancer post-R0 resection may also be enrolled onto the protocol any time before or up to 3 months post-surgery and prior to initiating adjuvant therapy.

Ability to understand and the willingness to sign a written informed consent document.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Therapy

Participants undergo neoadjuvant therapy with blood sample collection during each treatment

Varies per treatment cycle

Multiple visits during therapy

Surgical Resection

Participants undergo surgical resection with blood and tissue sample collection

1 day

1 visit (in-person)

Adjuvant Therapy

Participants may receive adjuvant therapy with monitoring of plasma alterations

Varies per treatment cycle

Multiple visits during therapy

Surveillance

Participants are monitored for recurrence with blood sample collection up to 4 times per year

Up to 5 years

Up to 4 visits per year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Minimal Residual Disease Assessment

How Is the Trial Designed?

Group I: Ancillary-correlative (biospecimen collection) Experimental Treatment 2 Interventions

Patients undergo collection of blood samples at baseline, during each neoadjuvant therapy treatment, prior to surgical resection, and up to 4 times per year for up to 5 years. Patients also undergo collection of tissue sample at time of surgical resection. Patients medical records may also be reviewed.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+