Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host
Recruiting · NCT02732860 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Princess Margaret Cancer Centre - Toronto, Ontario, Canada