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 : July 20, 2022
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Condition or disease | Intervention/treatment |
---|---|
Gastrointestinal Cancers | Genetic: NGS, PDO/PDX establishment |
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. |
- Establishment of an innovative model of a comprehensive precision oncology platform [ Time Frame: 4 years ]
- 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 ]
- Describe the prevalence of actionable genomic aberrations in patients with advanced cancers in Hong Kong [ Time Frame: 4 years ]
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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 |
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.
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.
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
Contact: Brigette MA, MD | 22939871 | brigette@clo.cuhk.edu.hk | |
Contact: Karen FUNG, BSc | 22939871 | karenfung@clo.cuhk.edu.hk |
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 |
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: | July 20, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases |