Molecular Study and Precision Medicine for Colorectal Cancer

Advanced Colorectal Carcinoma Clinical Trial

— MSPM  

Official title:

Precision Medicine for Advanced or Recurrent Colorectal Cancer Directed by High-throughput Sequencing and Tumor Organoids Model

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05883683
• Other study ID #: CIT-CoPT-R01
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2023
• Source: Wuhan Union Hospital, China
• Contact: Zheng Wang, MD/PhD
• Phone: +86 2785726612
• Email: zhengwang[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Colorectal Carcinoma
• Carcinoma
• Colorectal Neoplasms
• Recurrent Colorectal Carcinoma

Intervention

Other:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of clinical actionable alterations identified in native tumor and organoids.	Genomic gene mutation numbers are identified using the Next-Generation Sequencing (NGS).	Up to 3 years
Secondary	Correlation between organoid and PDX drug sensitivities	Size of the tumor is measured to reflect the drug response.	Up to 3 years