Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Monitoring blood markers to predict treatment response in rectal cancer

Official title: ctDNA Monitoring to Predict the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer

Run by Gene Solutions · NCT06589388 · Data updated 2026-11-12

This study is testing if measuring certain blood markers in patients with stage II and III rectal cancer can help predict how well they respond to treatment.

More Rectal Cancer trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment100 (estimated)
SponsorGene Solutions
Industry-sponsored
Drugs / interventionschemotherapy
Locations1 site (Ho Chi Minh City)
StatusRecruiting
StartedMay 21, 2024
Main results expectedDecember 2025
Study endsDecember 2027
Registry record updatedSeptember 19, 2024
Trial IDNCT06589388 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older diagnosed with stage II or III rectal cancer who are eligible for total neoadjuvant therapy.

Probably not a fit

Patients with stage I rectal cancer, recurrent or metastatic cancer, or those not consenting to participate will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the levels of circulating tumor DNA (ctDNA) in patients with stage II and III rectal cancer undergoing total neoadjuvant therapy (TNT). Blood samples will be collected at three key time points: before treatment, during treatment, and after treatment to assess changes in ctDNA levels. The study will also investigate the correlation between ctDNA levels and imaging results to predict the pathological complete response to therapy. Participants will be monitored for disease-free survival over a two-year period.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method to predict treatment efficacy and guide therapy decisions for rectal cancer patients.

How similar studies have gone: While the use of ctDNA monitoring in cancer treatment is gaining traction, this specific approach in rectal cancer with TNT is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 18 years and older, both genders
* Patients are diagnosed with stage II-III rectal cancer and indicated for total neoadjuvant therapy
* Biopsy FFPE sample is available at the time of diagnosis
* Patients consented to participate in the study

Exclusion Criteria:

* Stage I rectal cancer, recurrent or metastatic cancer
* Other cancer metastasis to the rectum
* Patients are indicated for chemoradiation therapy only
* Have been or are being treated for cancer
* Patients do not agree to participate in the studies.

Where it's running

  • Medical Genetics Institute
    Ho Chi Minh City, Vietnam
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.