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NCT Number: NCT06746298

A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for Rectal Cancer

This is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Objective Response Rate

    Time frame: From the start of the neoadjuvant therapy until just before surgery

    The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

    The time from the start of treatment to death due to any cause.

  2. Progression free survival

    Time frame: 3 years

    The period from the date of beginning treatment until the date of disease progression or death from any cause

  3. Total resection rate

    Time frame: One month after surgery

    Surgically removed tissue without residual cancer cells

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Minimally Invasive Surgery Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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