Not yet recruiting NCT06746298
A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for 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, Neoadjuvant Therapy. Basic parameters: from 18 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
- Center list to be confirmed — check the primary protocol.
- 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 →
Overview
This is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer.
Primary outcome measures
- Objective Response Rate [Time frame: From the start of the neoadjuvant therapy until just before surgery]
Secondary outcome measures (3)
- Overall survival [Time frame: 3 years]
- Progression free survival [Time frame: 3 years]
- Total resection rate [Time frame: One month after surgery]
Eligibility criteria
Inclusion criteria
- Age ≥18 years, male or infertile female
- Patients with rectal adenocarcinoma diagnosed by colonoscopic biopsy
- Neoadjuvant therapy according to guideline recommendations
- Endoscopic biopsy with access to biopsy tissue for subsequent RNA-seq testing
- Patients who do not have a combination of primary malignant tumors elsewhere.
- Patients who understand the purpose of the trial, participate voluntarily and sign an informed consent form.
Exclusion criteria
- Samples are not collected, stored, or processed in accordance with specified requirements
- Sample does not meet the requirements for subsequent RNA-seq testing
- Cases enrolled with a subsequent diagnosis other than rectal adenocarcinoma.
- The patient refuses or is unable to complete the entire neoadjuvant treatment
- Lack of post-neoadjuvant imaging results and lack of routine postoperative pathology results.
- Other patients who, in the judgment of the investigator, do not meet the enrollment requirements
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
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06746298 · RNA-seq-Neo