Investigating blood-based biomarkers in rectal cancer treatment
Timing To Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy For Rectal Cancer: A Multicenter Randomized Controlled Trial - Biomarkers SubStudy
This study is testing if certain tiny molecules in the blood can help track how well treatment is working for people with locally advanced rectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria Academic / other |
| Locations | 1 site (Alessandria) |
| Trial ID | NCT03962088 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiotherapy followed by surgery. It aims to identify microRNAs as potential blood-based biomarkers to monitor tumor response, addressing the need for valid biomarkers due to the heterogeneous response to treatment. By analyzing blood samples, the study seeks to provide a less invasive and more comprehensive method for assessing tumor sensitivity compared to traditional tissue biopsies. The research will involve extensive histopathological work-up of tumor specimens post-surgery to correlate with blood biomarker findings.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically-proven adenocarcinoma of the rectum who are eligible for neoadjuvant chemoradiotherapy and subsequent surgery.
Not a fit: Patients with metastatic disease or those unable to complete neoadjuvant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of treatment response in rectal cancer patients, allowing for more personalized treatment approaches.
How similar studies have performed: While there have been studies investigating tissue-based biomarkers, the exploration of blood-based microRNAs as biomarkers in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * cT3/4N0/+M0 confirmed on CT-scan, MRI (stratification for T3a-b-c-d) * Histologically-proven adenocarcinoma of the rectum * Eligible for a resective surgery with TME * Eligible for chemoradiation treatment Exclusion Criteria: * Metastatic disease * Squamous carcinoma of the anal canal * Unable to complete neoadjuvant treatment
Where this trial is running
Alessandria
- SS. Antonio e Biagio e Cesare Arrigo — Alessandria, Italy (Recruiting)
Study contacts
- Study coordinator: Igor Monsellato, PhD
- Email: igor.monsellato@ospedale.al.it
- Phone: +390131206078
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.