Gastrointestinal CancerNCT04611035
Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)
An observational study of Gastrointestinal Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- QPOP
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Jan 2020to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: At least 20 patients with gastric cancer, and 80 patients with other GI cancers will be first be recruited.
Who may be able to join
- -
- 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
Show all 29Show fewer
- 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
- Pre-treatment
- Bone marrow:
- Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin ≥ 8 x 109/L
- Hepatic:
- Bilirubin ≤ 1.5 x upper limit of normal (ULN),
- ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases)
- Renal:
- Creatinine ≤ 1.5x ULN
- Signed informed consent from patient or legal representative
- Able to comply with study-related procedures.
- Recovery from prior toxicity to G1, excluding alopecia.
Who cannot join
- There are no specific exclusion criteria if patients meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Wei Peng Yong, 6779 5555, Wei_Peng_Yong@nuhs.edu.sg
About this study
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.
Read the detailed description
Hypothesis: Ex-vivo sensitivity testing on patient derived tumour organoids using QPOP can identify drug combinations which may have clinical efficacy against metastatic gastrointestinal cancer.
Specific aim 1: To grow patients' gastrointestinal tumour-derived organoids.
Specific aim 2: To perform ex-vivo drug sensitivity testing on patient derived tumour organoids using QPOP for metastatic gastrointestinal cancers.
Specific aim 3: Asses the efficacy of phenotype directed therapy using QPOP to assign treatment after progression of standard of chemo for gastric cancer.
- Conditions
- Gastrointestinal Cancer
- Being tested
- QPOP
- Keywords
- Qpop
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QPOPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patient with first-line gastrointestinal cancers and patient with advanced and refractory GI cancers (>1 line of treatment), or post-progression biopsy) Receives: Device: QPOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of radiological response
complete and partial clinical response, including confidence intervals.
Measured: 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.
Measured: 3 years
Efficacy of second-line therapy
measured by Overall Response Rate for patients with gastric cancer.
Measured: 3 years
Secondary outcomes (1)
Haematologic and non-haematologic toxicities
Toxicity rating using the NCI CTC v4.03 scale
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start20 Jan 2020
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Peng Yong, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611035
- Sponsor's protocol ID
- 2019/00924
- Other IDs
- 2019
- Status last verified
- Apr 2022
- First submitted
- 26 Aug 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22810696AACR 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.
PubMed 28572459
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)
- ClinicalTrials.gov ID
- NCT04611035
- Acronym / sponsor ID
- 2019/00924
- Conditions
- Gastrointestinal Cancer
- Keywords
- Qpop
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis: Ex-vivo sensitivity testing on patient derived tumour organoids using QPOP can identify drug combinations which may have clinical efficacy against metastatic gastrointestinal cancer.
Specific aim 1: To grow patients' gastrointestinal tumour-derived organoids.
Specific aim 2: To perform ex-vivo drug sensitivity testing on patient derived tumour organoids using QPOP for metastatic gastrointestinal cancers.
Specific aim 3: Asses the efficacy of phenotype directed therapy using QPOP to assign treatment after progression of standard of chemo for gastric cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Device: QPOPPatient with first-line gastrointestinal cancers and patient with advanced and refractory GI cancers (>1 line of treatment), or post-progression biopsy) |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At least 20 patients with gastric cancer, and 80 patients with other GI cancers will be first be recruited.
Key inclusion criteria (29 listed)
- -
- 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
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria if patients meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QPOPQPOP 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. | Device | Patient |
Primary outcome
Rates of radiological response
Time frame: 3 years
complete and partial clinical response, including confidence intervals.
Percentage of patients with successful organoid generation for each different tumour type.
Time frame: 3 years
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.
Efficacy of second-line therapy
Time frame: 3 years
measured by Overall Response Rate for patients with gastric cancer.
1 secondary outcome
Haematologic and non-haematologic toxicities
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Results publication: PubMed 22810696Cancer Genome Atlas Network. Comprehensive molecular characterization of human colon and rectal cancer. Nature. 2012 Jul 18;487(7407):330-7. doi: 10.1038/nature11252.
- Results publication: PubMed 28572459AACR 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Peng Yong principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Peng Yong (6779 5555, Wei_Peng_Yong@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of radiological response (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04611035, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.