PRecision Oncology CUhk pRogrammE (PRO-CURE) | NCT04724070

Studies
PRecision Oncology CUhk pRogrammE (PRO-CURE)

NCT04724070

Sponsor

Brigette Ma

Status

Active, not recruiting

Last Update Posted

Jun 18, 2026Actual

Enrollment

170Actual

Phase

Not provided

Conditions

Gastrointestinal Cancers

Interventions

NGS, PDO/PDX establishment

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2019Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jan 21, 2021

First Submission Date that Met QC Criteria

Jan 21, 2021

First Posted Date

Jan 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NGS and PDO/PDX establishment			Genetic: NGS, PDO/PDX establishment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases