RightFit
RecruitingPhase not listed

Precision-MRD: Prospective Observational Study of Biomarker-directed Systemic Therapy for Colorectal Cancer Patients With Minimal Residual Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not stated
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people with colorectal cancer who still have cancer DNA in their blood after treatment, but no clear cancer on scans. It looks at how treatments chosen for specific cancer markers affect cancer DNA in the blood. The study does not choose treatment; each person's cancer doctor chooses it as part of usual care.

The goal of this clinical research study is to learn about the effects of biomarkertargeted therapy on ctDNA in patrticipants with CRC and MRD. This is an observational study. Participants will be monitored while receiving biomarker-directed therapy that is determined by your treating oncologist (cancer doctor) per standard of care, independent of this study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18.
  • Have colorectal adenocarcinoma, a cancer of the colon or rectum, confirmed by tissue or cell testing.
  • Have stage II–IV cancer with no clear cancer on scans after treatment to the cancer area. Unclear spots smaller than 10 mm may be allowed by the study leader.
  • Have one of these cancer markers on tumor or blood testing: BRAF V600E, KRAS G12C, MSI-H, or HER2 amplification. These are gene changes or features that help guide treatment.
  • Have a positive ctDNA test, which finds cancer DNA in blood, more than 21 days after surgery or the last dose of added treatment after surgery.
  • Be prescribed a usual treatment matched to your marker: a BRAF V600E or KRAS G12C blocker plus an anti-EGFR antibody; an anti-PD-1 antibody with or without an anti-CTLA-4 antibody for MMRd/MSI-H cancer; or anti-HER2 treatment for HER2 amplification. These drugs target cancer signals or help the immune system fight cancer.

Who can't join

  • Have already received any of these treatments: BRAF V600E blockers, anti-EGFR antibodies, KRAS G12C blockers, anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or anti-HER2 treatments.
  • Have another cancer that needs active treatment.
  • Cannot give informed consent, which means understanding the study and agreeing to join.
  • Be a child.
  • Be pregnant.
  • Have impaired thinking or understanding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria 1. Male or female subjects aged \> 18 years. 2. Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma. 3. Stage II-IV disease per current AJCC staging criteria with no definitive radiographic evidence of disease following locoregional treatment. Small indeterminate lesions measuring \< 10 mm may be permitted at the discretion of the principal investigator. 4. Presence of one of the following targetable biomarkers on tumor or blood molecular testing: BRAF V600E mutation (Cohort A), KRAS G12C mutation (Cohort B), MSI-H status (Cohort C), and HER2 amplification (Cohort D). 5. Positive ctDNA blood test obtained \> 21 days after surgery or last administration of adjuvant therapy. 6. Prescribed one of the following standard-of-care targeted therapy regimens: BRAF V600E Inhibitor + anti-EGFR antibody for BRAF V600E-mutated tumors, KRAS G12C Inhibitor + anti-EGFR antibody for KRAS G12C-mutated tumors, anti-PD-1 antibody +/- anti-CTLA-4 antibody for MMRd/MSI-H tumors, or anti-HER2 therapies for HER2 amplified tumors. Exclusion Criteria 1. Prior exposure to the following classes of biomarker-directed therapies: BRAF V600E inhibitors, anti-EGFR antibodies, KRAS G12C inhibitors, anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or anti-HER2 therapies 2. Presence of a concurrent malignancy requiring active treatment 3. Inability to provide informed consent 4. Children will not be enrolled in this study 5. Pregnant women will not be enrolled in this study 6. Cognitively Impaired subjects will not be enrolled in this study

Study sites (1)

TX