Colorectal NeoplasmsREFLECTNCT02732860
Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host
An observational study of Colorectal Neoplasms and Colorectal Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Cancer, Breast Cancer
- What is being tested?
- Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to 4 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with TNBC, CRC, HGSOC, or selected other tumour types, referred to, or being treated at Princess Margaret Cancer Centre.
Who may be able to join
- Age > 18 years.
- Patient diagnosis must be categorized as either (I) OR (II) OR (III) OR (IV):
- 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
- OR
Show all 18Show fewer
- 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
- OR
- 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
- OR
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Elizabeth Shah, 416-946-4501 ext. 3833, elizabeth.shah@uhn.ca
David Cescon, MD
About this study
Official title: Prospective Evaluation of Freshly Implanted Cancers in Mice to Test Drug Response in Matching Host
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
Read the detailed description
Personalized patient-derived xenografts (pPDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. pPDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual pPDX and patient responses to therapy. While encouraging, the role of this approach in breast, colorectal, ovarian, and other cancer populations and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of pPDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with TNBC, CRC, HGSOC and other selected tumor types.
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Breast Cancer, Breast Neoplasms, Ovarian Cancer, Ovarian Neoplasm
- Being tested
- Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures
- Keywords
- personalized patient-derived xenografts (pPDX), molecular profiling, epigenetic analysis, drug sensitivity testing, triple negative, metastatic, serous
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Profiling & In Vivo drug testing in pPDX and organoid culturesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures | |
| 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. Receives: Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures | |
| 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. Receives: Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures | |
| 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. Receives: Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 years
Rate of results reporting
Measured: up to 5 years
Rate of pPDX engraftment
Measured: up to 2 years
Secondary outcomes (3)
Comparison of actionable alterations identified in clinical and pPDX samples
Genomic alterations identified using the Ion Proton System for Next-Generation Sequencing (NGS).
Measured: up to 5 years
Number of patients with molecular abnormalities in pPDX as identified via NGS eliciting clinical responses while receiving matched treatments.
Overall accuracy of clinical responses as assessed by RECIST criteria in patient tumor.
Measured: up to 5 years
Correlation between pPDX and organoid drug sensitivities
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startDec 2015
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Cescon, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732860
- Sponsor's protocol ID
- REFLECT-001
- Acronym
- REFLECT
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2016
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Freshly Implanted Cancers in Mice to Test Drug Response in Matching Host
- ClinicalTrials.gov ID
- NCT02732860
- Acronym / sponsor ID
- REFLECT / REFLECT-001
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Breast Cancer, Breast Neoplasms, Ovarian Cancer, Ovarian Neoplasm
- Keywords
- personalized patient-derived xenografts (pPDX), molecular profiling, epigenetic analysis, drug sensitivity testing, triple negative, metastatic, serous
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Jan 2027 (estimated)
- First posted
- 11 Apr 2016 (estimated)
- 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.
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
Detailed description
Personalized patient-derived xenografts (pPDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. pPDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual pPDX and patient responses to therapy. While encouraging, the role of this approach in breast, colorectal, ovarian, and other cancer populations and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of pPDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with TNBC, CRC, HGSOC and other selected tumor types.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Triple Negative Breast Cancer | – | Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid culturesTriple 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 | – | Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid culturesColorectal 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 | – | Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid culturesHigh 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: Molecular Profiling & In Vivo drug testing in pPDX and organoid culturesOther 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with TNBC, CRC, HGSOC, or selected other tumour types, referred to, or being treated at Princess Margaret Cancer Centre.
Key inclusion criteria (18 listed)
- Age > 18 years.
- Patient diagnosis must be categorized as either (I) OR (II) OR (III) OR (IV):
- OR
- OR
- OR
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Molecular Profiling & In Vivo drug testing in pPDX and organoid culturesMolecular 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. | Other | Colorectal Cancer, High Grade Serous Ovarian Cancer, Other tumor types, Triple Negative Breast Cancer |
Primary outcome
Measure of drug sensitive pPDX to a panel of drugs as a predictor of clinical response in matched host
Time frame: up to 5 years
Sensitivity measured by tumor growth inhibition (>80%) or objective tumor response (regression) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Rate of results reporting
Time frame: up to 5 years
Rate of pPDX engraftment
Time frame: up to 2 years
3 secondary outcomes
Comparison of actionable alterations identified in clinical and pPDX samples
Time frame: up to 5 years
Number of patients with molecular abnormalities in pPDX as identified via NGS eliciting clinical responses while receiving matched treatments.
Time frame: up to 5 years
Correlation between pPDX and organoid drug sensitivities
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
David Cescon, MD principal investigator
Princess Margaret Cancer Centre
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 Colorectal Neoplasms and Colorectal Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 18 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 May 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Cescon, MD (416-946-2245, Dave.Cescon@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of drug sensitive pPDX to a panel of drugs as a predictor of clinical response in matched host (time frame: up to 5 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?
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 4 May 2026.