Clinical trial NCT05883683: Molecular Study and Precision Medicine for Colorectal Cancer
Official title: Precision Medicine for Advanced or Recurrent Colorectal Cancer Directed by High-throughput Sequencing and Tumor Organoids Model
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Advanced Colorectal Carcinoma
Recurrent Colorectal Carcinoma
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with advanced or recurrent colorectal cancer

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.

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

Primary outcomes:
measure: Identification of effective drugs or drug combinations
timeFrame: up to 3 years
Secondary outcomes:
measure: Comparison of clinical actionable alterations identified in native tumor and organoids.
timeFrame: Up to 3 years
measure: Correlation between organoid and PDX drug sensitivities
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital, China
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Zheng Wang, MD/PhD
role: STUDY_CHAIR
References:
citation: 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.