Molecular Study and Precision Medicine for Colorectal Cancer

NCT ID: NCT05883683

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-07-01

Brief 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.

Conditions

Advanced Colorectal Carcinoma; Recurrent Colorectal Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Colorectal Cancer

Colorectal cancer patients with advanced or recurrent tumors

Molecular Profiling & drug testing in tumor organoids and PDXs

Intervention Type: OTHER

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.

Interventions

Molecular Profiling & drug testing in tumor organoids and PDXs

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Zheng Wang, MD/PhD

Study chair, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zheng Wang, MD/PhD

Role: STUDY_CHAIR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

Wuhan Union Hospital, China

Wuhan, Hubei, China

Countries

China

Central Contacts

Zheng Wang, MD/PhD

Role: CONTACT

zhengwang@hust.edu.cn

+86 2785726612

Luming Xu

Role: CONTACT

lumingxu@hust.edu.cn

+86 2785726612

Facility Contacts

Zheng Wang, MD/PhD

Role: primary

+86278576612

References

Pauli C, Hopkins BD, Prandi D, Shaw R, Fedrizzi T, Sboner A, Sailer V, Augello M, Puca L, Rosati R, McNary TJ, Churakova Y, Cheung C, Triscott J, Pisapia D, Rao R, Mosquera JM, Robinson B, Faltas BM, Emerling BE, Gadi VK, Bernard B, Elemento O, Beltran H, Demichelis F, Kemp CJ, Grandori C, Cantley LC, Rubin MA. Personalized In Vitro and In Vivo Cancer Models to Guide Precision Medicine. Cancer Discov. 2017 May;7(5):462-477. doi: 10.1158/2159-8290.CD-16-1154. Epub 2017 Mar 22.

Reference Type: BACKGROUND

PMID: 28331002 (View on PubMed)

Other Identifiers

CIT-CoPT-R01

Identifier Type: -

Identifier Source: org_study_id