A Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Colorectal Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method

NCT06100016 | Recruiting

• 1 other identifier: ZKPRS-CMU1H-02
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a real-world observational clinical study. Patients diagnosed as colorectal cancer through histopathology were screened and enrolled. Before anti-tumor treatment, colonoscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in colorectal cancer treatment and drug susceptibility outcomes.

Conditions

Colorectal Cancer; Organoids

Outcome Measures

Primary Outcomes (3)

• Disease-free survival

  An Indicator of efficacy of postoperative adjuvant therapy

  From date of surgery until the date of first documented recurrence，up to 3 years

• Sensitivity

  Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as apercentage of the cases that are effective in clinical evaluation

  Through study completion, an average of 1 year

• Specificity

  Cases in which drug susceptibility results are resistance to the antineoplastic regimen as apercentage of the cases that are ineffective in clinical evaluation

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with colorectal cancer in the First Affiliated Hospital of China Medical University

You may qualify if:

• Male or female, aged ≥ 18 and ≤80;
• Patients with colorectal cancer diagnosed by histopathology;
• Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment;
• Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained;
• Patients who sign the informed consent form, and are able to comply with the study period treatment process.

You may not qualify if:

• Inability to follow the research protocol;
• Inability to obtain relevant fresh specimens by biopsy/surgery/puncture;
• Concomitant contraindications to chemotherapy;
• pregnant or lactating women;
• Patients deemed inappropriate by investigators.

Sponsors & Collaborators

• Funan Liu: lead
• Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences: collaborator
• Precedo Pharmaceuticals Co. Ltd.: collaborator
• Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China: collaborator

Study Sites (1)

Phase I Clinical Trials Center Of The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zhenning Wang, doctor

  The First Affiliated Hospital of China Medical Univeristy

  PRINCIPAL INVESTIGATOR

• Funan Liu, doctor

  The First Affiliated Hospital of China Medical Univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuhui Song, bachelor

CONTACT

02483281137; 593900927@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 25, 2023
• Study Start: October 18, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 1, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)