NCT02732860 Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host
| NCT ID | NCT02732860 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Colorectal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2015-12 |
| Primary Completion | 2027-01-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2015-12 with a primary completion date of 2027-01-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: 1. Age \> 18 years. 2. 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 OR (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 OR (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 OR (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 3. Disease amenable to biopsy or surgery for tissue procurement 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. Willingness and ability of patient to provide signed voluntary informed consent. Exclusion Criteria: 1. Clinically significant hepatic, renal, cardiac or other organ dysfunction likely to limit participation in clinical trials. 2. Known brain metastasis 3. Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment. 4. Any contraindication to undergoing a biopsy procedure.
Contact & Investigator
David Cescon, MD
PRINCIPAL INVESTIGATOR
Princess Margaret Cancer Centre
Frequently Asked Questions
Who can join the NCT02732860 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02732860 currently recruiting?
Yes, NCT02732860 is actively recruiting participants. Contact the research team at Dave.Cescon@uhn.ca for enrollment information.
Where is the NCT02732860 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT02732860 clinical trial?
NCT02732860 is sponsored by University Health Network, Toronto. The principal investigator is David Cescon, MD at Princess Margaret Cancer Centre. The trial plans to enroll 120 participants.