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PRecision Oncology CUhk pRogrammE (PRO-CURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04724070
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Brigette Ma, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment
Gastrointestinal Cancers Genetic: NGS, PDO/PDX establishment

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Precision Oncology Program at The Chinese University of Hong Kong
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

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.




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

Secondary Outcome Measures :
  1. Describe the prevalence of actionable genomic aberrations in patients with advanced cancers in Hong Kong [ Time Frame: 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04724070


Contacts
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Contact: Brigette MA, MD 22939871 brigette@clo.cuhk.edu.hk
Contact: Karen FUNG, BSc 22939871 karenfung@clo.cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Brigette MA, MD    22939871    brigette@clo.cuhk.edu.hk   
Contact: Karen FUNG, BSc    22939871    karenfung@clo.cuhk.edu.hk   
Sponsors and Collaborators
Brigette Ma
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Responsible Party: Brigette Ma, Professor, Department of Clinical Oncology, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04724070    
Other Study ID Numbers: PROCURE
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases