PRecision Oncology CUhk pRogrammE (PRO-CURE)

NCT04724070 | Recruiting

• 1 other identifier: PROCURE
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Describe the prevalence of actionable genomic aberrations in patients with advanced cancers in Hong Kong

  4 years

Study Arms (1)

NGS and PDO/PDX establishment

Genetic: NGS, PDO/PDX establishment

Interventions

NGS, PDO/PDX establishment GENETIC

Patients' tumor specimens will be collected for next generation sequencing, PDO/PDX establishment and tissue banking.

NGS and PDO/PDX establishment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigette Ma: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Brigette MA, MD

CONTACT

22939871; brigette@clo.cuhk.edu.hk

Alice KONG, PC

CONTACT

22939871; alice@clo.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Clinical Oncology

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: October 16, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)