Using blood tests to improve treatment strategies for rectal cancer
Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
This study is testing if measuring tumor DNA in the blood can help doctors see how well treatments are working for people with stage II-III rectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Locations | 2 sites (Portland, Oregon and 1 other locations) |
| Trial ID | NCT05081024 on ClinicalTrials.gov |
What this trial studies
This observational study measures circulating tumor DNA (ctDNA) levels in patients with stage II-III rectal cancer before, during, and after treatment. The goal is to determine if ctDNA presence or absence can indicate how well different treatments are working. Participants will provide blood samples at various intervals, and their medical records will be reviewed to assess treatment outcomes. The study aims to correlate ctDNA levels with clinical responses and survival rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically-confirmed stage II or III primary adenocarcinoma of the rectum.
Not a fit: Patients with distant metastases or those who have received prior treatment for rectal adenocarcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for rectal cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using ctDNA as a biomarker for treatment response, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant must provide written informed consent before any study-specific procedures or interventions are performed * Participants aged \>= 18 years * Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum: * T3N0M0 - T4bN2M0 Exclusion Criteria: * Has radiologic evidence of distant metastases at the time of screening/enrollment * Has received prior treatment for their rectal adenocarcinoma * Requires or has received blood transfusion within 1 month of study enrollment
Where this trial is running
Portland, Oregon and 1 other locations
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Recruiting)
- Fred Hutch — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Adel Kardosh, M.D.,Ph.D. — OHSU Knight Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.