PRecision Oncology CUhk pRogrammE (PRO-CURE)

Recruiting

• Conditions: Gastrointestinal Cancers
• Interventions: Genetic: NGS, PDO/PDX establishment

• Registration Number: NCT04724070
• Lead Sponsor: Brigette Ma

Brief Summary

The main aim of this project is to establish an innovative model of a comprehensive precision oncology platform to help individualizing drug therapy for patients with advanced cancers at The Chinese University of Hong Kong. The other objectives include to optimize the genomic matching and access of patients with unique cancer subtypes to the relevant clinical trials of novel therapies, and to construct a personalized drug screening platform for individuals using novel cancer models established from patient-derived cancer cells and tissues. Other objectives include to investigate the utility and feasibility of genomic sequencing using circulating tumor DNA(ctDNA), and to establish a biobank of tumor tissues derived from patients with unique cancer subtypes.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-16
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Must be aged between 18 to 75 years
• Must have ECOG performance status of 0 to 1
• Must have histologically/cytologically confirmed cancers of certain subtype
• Medically fit patients who would need systemic therapy as part of their oncological treatment in any one or more of the following oncological setting(s): palliative, neoadjuvant, adjuvant, concurrent with radiotherapy. This includes patients who have limited systemic therapeutic options for their cancers and are candidates for clinical trials.
• Able to give written informed consent
• Willing to have blood samples taken.
• Availability of an archived paraffin-embedded tumor block

Exclusion Criteria

• Patients who refuse or are medically unfit for systemic therapy for their cancer
• Patients with more than one invasive cancers diagnosed over the last FIVE years.
• Patients without measurable tumor lesions on radiological imaging
• Patients who are unable to give written informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NGS and PDO/PDX establishment	NGS, PDO/PDX establishment	-

Primary Outcome Measures

Name	Time	Method
Construction of a personalized drug screening platform for individuals using novel cancer models established from patient-derived cancer cells and tissues.	4 years
Establishment of an innovative model of a comprehensive precision oncology platform	4 years

Secondary Outcome Measures

Name	Time	Method
Describe the prevalence of actionable genomic aberrations in patients with advanced cancers in Hong Kong	4 years

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong