Clinical trial · Observational
Molecular Study and Precision Medicine for Colorectal Cancer
Precision Medicine for Advanced or Recurrent Colorectal Cancer Directed by High-throughput Sequencing and Tumor Organoids Model
NCT05883683CI-TRIAL-00079075MSPMunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular Profiling & drug testing in tumor organoids and PDXs | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Colorectal Cancer
- description
- Colorectal cancer patients with advanced or recurrent tumors
- interventionNames
- Other: Molecular Profiling & drug testing in tumor organoids and PDXs
Primary outcomes (1)
- measure
- Identification of effective drugs or drug combinations
- timeFrame
- up to 3 years
- description
- Viability of organoid is measured using CellTiter-Glo by quantifying ATP, which indicates the presence of metabolically active cells.
Secondary outcomes (2)
- measure
- Comparison of clinical actionable alterations identified in native tumor and organoids.
- timeFrame
- Up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDPauli 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