PRecision Oncology CUhk pRogrammE (PRO-CURE)

Gastrointestinal Cancers Clinical Trial

Official title:

Comprehensive Precision Oncology Program at The Chinese University of Hong Kong

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724070
• Other study ID #: PROCURE
• Status: Recruiting
• Start date: October 16, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Chinese University of Hong Kong
• Contact: Brigette MA, MD
• Phone: 22939871
• Email: brigette[@]clo.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancers
• Gastrointestinal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Brigette Ma

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of an innovative model of a comprehensive precision oncology platform		4 years
Primary	Construction of a personalized drug screening platform for individuals using novel cancer models established from patient-derived cancer cells and tissues.		4 years
Secondary	Describe the prevalence of actionable genomic aberrations in patients with advanced cancers in Hong Kong		4 years