Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rectal Cancer, Cancer of Rectum, Cancer of the Rectum, Neoplasms, Rectal. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.
Overview
Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.
Detailed description
According to postoperative pathological examination results, all participants will be divided into two groups: complete response (ypT0N0) and poor response (\>ypT1-2N0). Differentially expressed genes between complete response and poor response will be analyzed. A scoring formula will be established based on the results. Tumor tissue samples are collected before neoadjuvant therapy and will be analyzed via RNA sequencing.
Primary outcome measures
- Comparing gene expression differences between poor response group and complete response group by using RNA sequencing. [Time frame: 6 months]
Secondary outcome measures (2)
- Overall survival(OS) [Time frame: 3 years]
- Progression Free Survival(PFS) [Time frame: 3 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 2 centers
- Wuhan Union Hospital — Wuhan
- Hubei Cancer Hospital — Wuhan
Publications
- Chang GJ, Park IJ, You YN, et al. Neoadjuvant treatment response and outcomes in locally advanced rectal cancer: Establishing oncologic benchmarks. Journal of Clinical Oncology 29(15):3545-3545,2011.
Identifiers
NCT: NCT03573791 · WHUHGE-R01