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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06746298

Enrollment

118

Registered

2024-12-24

Start date

2025-01-01

Completion date

2027-05-31

Last updated

2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoadjuvant Therapy, Rectal Cancer

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate	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

Measure	Time frame	Description
Overall survival	3 years	The time from the start of treatment to death due to any cause.
Progression free survival	3 years	The period from the date of beginning treatment until the date of disease progression or death from any cause
Total resection rate	One month after surgery	Surgically removed tissue without residual cancer cells

Contacts

Primary ContactJing Sun

sj117788@rjh.com.cn+86-13524284622

Outcome results