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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03573791
Other study ID # WHUHGE-R01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 21, 2018
Est. completion date May 21, 2026

Study information

Verified date December 2023
Source Wuhan Union Hospital, China
Contact Zheng Wang, MD/PhD
Phone +86 27 85726612
Email zhengwang@hust.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 152
Est. completion date May 21, 2026
Est. primary completion date May 21, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 ?-? 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.

Study Design


Locations

Country Name City State
China Hubei Cancer Hospital Wuhan Hubei
China Wuhan Union Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Comparing gene expression differences between poor response group and complete response group by using RNA sequencing. Using RNA-seq sequencing method to obtain the whole genome transcription profiles of the poor response group and complete response group, and compare the gene expression differences between these two groups. 6 months
Secondary Overall survival(OS) The total survival time of the participants from joining the group to the death. If the death time is unknown, the relevant participants will be excluded for analysis. 3 years
Secondary Progression Free Survival(PFS) The time period that from participants joining the groups to the progression of disease(recurrence or metastasis) or death of any cause. 3 years
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