PRecision Oncology CUhk pRogrammE (PRO-CURE)

Comprehensive Precision Oncology Program at The Chinese University of Hong Kong

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Cancers
• Intervention / Treatment: Genetic: NGS, PDO/PDX establishment

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Brigette MA, MD; Phone Number: 22939871; Email: brigette@clo.cuhk.edu.hk
• Study Contact Backup: Name: Alice KONG, PC; Phone Number: 22939871; Email: alice@clo.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Brigette MA, MD; Phone Number: 22939871; Email: brigette@clo.cuhk.edu.hk
    • Contact: Alice KONG, PC; Phone Number: 22939871; Email: alice@clo.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The cancer types that are allowed in this study:

• Gastrointestinal cancers: esophageal cancer, colorectal cancer, gastric cancer, esophago-gastric junction cancer, pancreatic cancer (including neuroendocrine cancers), small bowel cancer, appendiceal cancer, anal cancer.
• Cancers that are known to carry unique genomic aberrations that are clinically relevant and/or potentially actionable.

Excluded types of neoplastic or dysplastic disorders:

- Lymphoma, leukemia, lymphoproliferative disease, plasma cell neoplasms, histiocytosis-related proliferative disorders.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NGS and PDO/PDX establishment	Genetic: NGS, PDO/PDX establishment; Patients' tumor specimens will be collected for next generation sequencing, PDO/PDX establishment and tissue banking.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Describe the prevalence of actionable genomic aberrations in patients with advanced cancers in Hong Kong	4 years

Collaborators and Investigators

• Sponsor: Brigette Ma

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: PROCURE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No