Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)

NCT04611035 | Unknown

• 1 other identifier: 2019/00924
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-cohort proof of concept study involving patients with metastatic gastrointestinal cancers. In the first cohort of treatment-naïve patients, the investigators intend to create cancer organoids for 100 subjects. Then, the investigators intend to evaluate ex-vivo prediction of treatment outcomes using QPOP (see section 4.0 for detailed sample size calculation). Patients enrolled on study will undergo a fresh biopsy of tumour lesion to obtain cells that will be used to generate patient-derived tumour organoids. These patients will go on to receive standard of care first-line chemotherapy +/- targeted therapy. Organoids will then be subjected to up to a 14-drug panel screening. The drugs in the respective drug panel have been shown to have activity in the respective cancers and would be used in the standard-of-care setting by treating physicians.

Conditions

Gastrointestinal Cancer

Keywords

Qpop

Outcome Measures

Primary Outcomes (3)

• Rates of radiological response

  complete and partial clinical response, including confidence intervals.

  3 years

• Percentage of patients with successful organoid generation for each different tumour type.

  Patients enrolled on study will undergo a fresh biopsy of tumour lesion to obtain cells that will be used to generate patient-derived tumour organoids.

  3 years

• Efficacy of second-line therapy

  measured by Overall Response Rate for patients with gastric cancer.

  3 years

Secondary Outcomes (1)

• Haematologic and non-haematologic toxicities

  3 years

Study Arms (1)

Patient

Patient with first-line gastrointestinal cancers and patient with advanced and refractory GI cancers (\>1 line of treatment), or post-progression biopsy)

Device: QPOP

Interventions

QPOP DEVICE

QPOP will then be applied to establish the most efficacious drug combination for the specific organoid. Additional drugs other than those listed above may be screened depending on availability of cancer organoids. When patients progress after first-line treatment, QPOP generated second-line options will be informed to treating physicians and the physician will exercise his/her discretion to select the most suitable drug based on patient's comorbidities and organ function after a formal molecular/phenotype tumour board.

Patient

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least 20 patients with gastric cancer, and 80 patients with other GI cancers will be first be recruited.

You may qualify if:

• Patients may be included in the study only if they meet the following criteria:
• Treatment naïve patient with gastrointestinal cancers (i.e. oesophageal, gastro-oesophgeal, gastric, small bowel, colorectal, hepatocellular, pancreatic and biliary tract) fit and planned for first line treatment, OR
• Chemo-refractory patients with GI cancers deemed by investigator to be fit for clinical trial
• Age ≥ 21 years
• ECOG PS 0-1
• At least 1 tumour lesion amenable to fresh biopsy
• At least 1 measurable tumour lesion based on RECIST v 1.1 criteria
• Estimated life expectancy of at least 24 weeks
• Adequate organ function , including:
• Pre-biopsy
• o Bone marrow:
• Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Pro-Thrombin within ULN
• Hemoglobin ≥ 8 x 109/L

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (2)

• Cancer Genome Atlas Network. Comprehensive molecular characterization of human colon and rectal cancer. Nature. 2012 Jul 18;487(7407):330-7. doi: 10.1038/nature11252.

  PMID: 22810696 RESULT

• AACR Project GENIE Consortium. AACR Project GENIE: Powering Precision Medicine through an International Consortium. Cancer Discov. 2017 Aug;7(8):818-831. doi: 10.1158/2159-8290.CD-17-0151. Epub 2017 Jun 1.

  PMID: 28572459 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

1.1 Tumour biopsies * maximum of 2 time points - baseline upon study enrolment and upon disease progression. Whenever possible, the tumour core biopsies will be performed under image guidance. * Up to 6 fresh core samples (each of Tumour and matched Adjacent-Normal/Non-Tumour) will be biopsied from each patient at each time-point. 1.2 Blood -A total of 50ml or 3.5 tablespoons of blood will be taken during screening of the study. A total of 40mls or 2.5 tablespoons of blood will be taken prior to each chemotherapy cycle. At the end of study, a total of 40mls or 2.5 tablespoons of blood will be collected. In total, a maximum of about 330ml or 22 tablespoons of blood will be taken during the course of this study.

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Wei Peng Yong

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Peng Yong

CONTACT

6779 5555; Wei_Peng_Yong@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: November 2, 2020
• Study Start: January 20, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)