Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host
REFLECT
Prospective Evaluation of Freshly Implanted Cancers in Mice to Test Drug Response in Matching Host
1 other identifier
observational
120
1 country
1
Brief Summary
By obtaining clinical specimens from participants with triple negative breast cancer (TNBC), colorectal cancer (CRC), high grade serous ovarian cancer (HGSOC), and other select tumor types to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with personalized cancer treatment options
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 4, 2027
May 4, 2026
April 1, 2026
11.1 years
February 10, 2016
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Measure of drug sensitive pPDX to a panel of drugs as a predictor of clinical response in matched host
Sensitivity measured by tumor growth inhibition (\>80%) or objective tumor response (regression) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
up to 5 years
Rate of results reporting
up to 5 years
Rate of pPDX engraftment
up to 2 years
Secondary Outcomes (3)
Comparison of actionable alterations identified in clinical and pPDX samples
up to 5 years
Number of patients with molecular abnormalities in pPDX as identified via NGS eliciting clinical responses while receiving matched treatments.
up to 5 years
Correlation between pPDX and organoid drug sensitivities
up to 5 years
Study Arms (4)
Triple Negative Breast Cancer
Triple negative breast cancer patients with residual invasive disease following neoadjuvant chemotherapy (n= up to 15) or with newly diagnosed metastatic disease (n=up to 30). After the screening procedures confirms patient eligibility: * Molecular Profiling will be performed on clinical sample * pPDX generation for in vivo drug testing * In vitro organoid culture generation (if sufficient fresh tissue available) * Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.
Colorectal Cancer
Colorectal cancer patients with metastatic disease undergoing resection of liver metastases, or with lesions amenable to biopsy (n=up to 15). After the screening procedures confirms patient eligibility: * Molecular Profiling will be performed on clinical sample * pPDX generation for in vivo drug testing * In vitro organoid culture generation (if sufficient fresh tissue available) * Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.
High Grade Serous Ovarian Cancer
High grade serous ovarian cancer patients with recurrent disease with a life expectancy of at least 12 months (n=up to 15), or Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence (n=up to 15). After the screening procedures confirms patient eligibility: * Molecular Profiling will be performed on clinical sample * pPDX generation for in vivo drug testing * In vitro organoid culture generation (if sufficient fresh tissue available) * Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.
Other tumor types
Other selected tumor types at the discretion of the PI (n= up to 30) After the screening procedures confirms patient eligibility: * Molecular Profiling will be performed on clinical sample * pPDX generation for in vivo drug testing * In vitro organoid culture generation (if sufficient fresh tissue available) * Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.
Interventions
Molecular profiling of host tumour sample and pPDX will be performed and analyzed by an expert panel. In vitro organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo pPDX drug testing results will be made, if available. This recommendation will be communicated to the primary oncologist.
Eligibility Criteria
Patients with TNBC, CRC, HGSOC, or selected other tumour types, referred to, or being treated at Princess Margaret Cancer Centre.
You may qualify if:
- Age \> 18 years.
- Patient diagnosis must be categorized as either (I) OR (II) OR (III) OR (IV):
- (I) Histologically confirmed Triple Negative Breast Cancer by Institutional and American Society of Clinical Oncology (ASCO)/Cancer of American Pathologists (CAP) guidelines, either:
- Stage IV (metastatic) disease that has not been treated with systemic therapy in the metastatic setting or
- Stage I to III (non-metastatic) with residual mass by clinical exam and/or breast imaging following anthracycline + taxane-containing neoadjuvant chemotherapy
- (II) Histologically-confirmed Stage IV colorectal cancer treated with ≤ 1 line of systemic therapy in the metastatic setting, either:
- Undergoing surgical resection of liver metastases or
- With metastatic lesions amenable to biopsy
- (III) Histologically-confirmed advanced High Grade Serous Ovarian Cancer, either:
- Recurrent disease with a life expectancy of at least 12 months or
- Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence
- (IV) Histologically confirmed solid tumor not meeting criteria for (I), (II) or (III) above, for which evaluation of investigational therapies is of particular interest or where clinical need exists, at the discretion of the PI
- Disease amenable to biopsy or surgery for tissue procurement
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Willingness and ability of patient to provide signed voluntary informed consent.
You may not qualify if:
- Clinically significant hepatic, renal, cardiac or other organ dysfunction likely to limit participation in clinical trials.
- Known brain metastasis
- Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
- Any contraindication to undergoing a biopsy procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Biospecimen
Whole Blood, formalin fixed paraffin embedded blocks, fresh tumor tissue, malignant effusion or ascites (if no tumor tissue available), archival tissue (if not enrolled in molecular profiling studies IMPACT/OCTANE)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Cescon, MD
Princess Margaret Cancer Centre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2016
First Posted
April 11, 2016
Study Start
December 1, 2015
Primary Completion (Estimated)
January 4, 2027
Study Completion (Estimated)
January 4, 2027
Last Updated
May 4, 2026
Record last verified: 2026-04