Molecular Study and Precision Medicine for Colorectal Cancer

Trial Title: Molecular Study and Precision Medicine for Colorectal Cancer

NCT ID: NCT05883683

Condition: Advanced Colorectal Carcinoma
Recurrent Colorectal Carcinoma

Conditions: Official terms:
Carcinoma
Colorectal Neoplasms

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Molecular Profiling & drug testing in tumor organoids and PDXs
Description: Molecular profiling of native tumor will be performed and analyzed by using a self-designed panel. Tumor organoids will be cultured from fresh tumor tissues and patient-derived xenografts model will be established using the tumor organoids. Drugs will be tested in the two models. And the recommendation will be communicated to the clinicians.
Arm group label: Colorectal Cancer

Summary: Researchers collect specimens from advanced or recurrent colorectal cancer (CRC) patients to conduct molecular profiling and establish tumor organoids (PDOs)/ patient-derived xenografts (PDXs). The aim of this study is to identify clinical actionable targets and predict in vivo response of the tumor to targeted drugs by using PDOs/ PDXs. And the above-mentioned studies will provide the patients with potential personalized cancer treatment options.

Detailed description: Patient-derived organoid is a model that can recapitulate the histology and behavior of the cancer from which it is derived, and is increasingly used as a tool for drug development in pre-clinical settings. Clinical treatment option of colorectal cancer now is quite limited. By molecular profiling, clinical actionable alterations may be identified. And according to the genomic investigation results, we can find the matched targeted drugs, following further testing in the organoids and PDXs. This will provide an opportunity to guide the precision medicine.

Criteria for eligibility:

Study pop:
patients with advanced or recurrent colorectal cancer

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Male or female patients, age 18 to 75 years old - Patients with a documented (histologically- or cytologically-proven) advanced or recurrent colorectal cancer - Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months - Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for 3 months after the last dose of study drug. - Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol. Exclusion Criteria: - Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug - Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy - Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first study drug administration. - Patients with a history of human immunodeficiency virus (HIV) or any other immunodeficiency disease. - Patients who are currently using certain drugs that are not permitted - Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies - Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Wuhan Union Hospital, China

Address:
City: Wuhan
Country: China

Contact:
Last name: Zheng Wang, MD/PhD

Phone: +86278576612

Start date: October 1, 2024

Completion date: July 1, 2026

Lead sponsor:
Agency: Wuhan Union Hospital, China
Agency class: Other

Source: Wuhan Union Hospital, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05883683