Clinical trial NCT04724070: PRecision Oncology CUhk pRogrammE (PRO-CURE)
Official title: Comprehensive Precision Oncology Program at The Chinese University of Hong Kong
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Cancers
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Establishment of an innovative model of a comprehensive precision oncology platform
timeFrame: 4 years
measure: Construction of a personalized drug screening platform for individuals using novel cancer models established from patient-derived cancer cells and tissues.
timeFrame: 4 years
Secondary outcomes:
measure: Describe the prevalence of actionable genomic aberrations in patients with advanced cancers in Hong Kong
timeFrame: 4 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: