Identifying biomarkers to predict resistance to neoadjuvant therapy in rectal cancer
Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.
This study is trying to find markers in tumor samples from patients with advanced rectal cancer to see if they can predict who will not benefit from a specific treatment before it starts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Wuhan, Hubei and 1 other locations) |
| Trial ID | NCT03573791 on ClinicalTrials.gov |
What this trial studies
This study aims to identify biomarkers from tumor samples of patients with middle-low advanced rectal cancer to predict their resistance to neoadjuvant chemoradiotherapy. By analyzing differentially expressed genes between patients who respond well and those who do not, the researchers will develop a scoring formula to help stratify patients. This approach seeks to avoid unnecessary treatment for patients unlikely to benefit from neoadjuvant therapy. Tumor tissue samples will be collected prior to treatment and analyzed using RNA sequencing.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with adenocarcinoma of the rectum, staged II-III, who have not undergone prior chemotherapy, radiotherapy, or immunotherapy.
Not a fit: Patients with intestinal obstruction, perforation, or other malignancies within the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans for rectal cancer patients, improving outcomes and reducing unnecessary therapies.
How similar studies have performed: While the approach of identifying biomarkers for treatment resistance is gaining traction, this specific study's methodology is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathology proved to be adenocarcinoma of the rectum. * The edge of tumor is within 12cm of anus margin. * According to the eighth edition of AJCC TNM staging standard ,that staging for Ⅱ-Ⅲ period, as T3-T4, N0 or any T, N1-2. * There is no history of chemotherapy, radiotherapy or immunotherapy before neoadjuvant therapy. * Understand and agree to sign the informed consent for the study. Exclusion Criteria: * With intestinal obstruction or impending obstruction, or perforation. * With other malignancies occurred within 5 years.
Where this trial is running
Wuhan, Hubei and 1 other locations
- Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)
- Hubei Cancer Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Zheng Wang, MD/PhD
- Email: zhengwang@hust.edu.cn
- Phone: +86 27 85726612
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.