Molecular Study and Precision Medicine for Colorectal Cancer

NCT05883683 | Not Yet Recruiting

• 1 other identifier: CIT-CoPT-R01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Colorectal Carcinoma; Recurrent Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Identification of effective drugs or drug combinations

  Viability of organoid is measured using CellTiter-Glo by quantifying ATP, which indicates the presence of metabolically active cells.

  up to 3 years

Secondary Outcomes (2)

• Comparison of clinical actionable alterations identified in native tumor and organoids.

  Up to 3 years

• Correlation between organoid and PDX drug sensitivities

  Up to 3 years

Study Arms (1)

Colorectal Cancer

Colorectal cancer patients with advanced or recurrent tumors

Other: Molecular Profiling & drug testing in tumor organoids and PDXs

Interventions

Molecular Profiling & drug testing in tumor organoids and PDXs 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.

Colorectal Cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with advanced or recurrent colorectal cancer

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Wuhan Union Hospital, China

Wuhan, Hubei, China

Location

Related Publications (1)

• 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.

  PMID: 28331002 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tumour samples will be collected for molecular characterization and organoids establishment.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Evaluation

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

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Zheng Wang, MD/PhD

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

  STUDY CHAIR

Central Study Contacts

Zheng Wang, MD/PhD

CONTACT

+86 2785726612; zhengwang@hust.edu.cn

Luming Xu

CONTACT

+86 2785726612; lumingxu@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study chair, Clinical Professor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: June 1, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)