Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-04-10 @ 3:15 AM
Study NCT ID:
NCT02752932
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2016-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Xenograft
Brief Summary:
Primary objectives:
1. Evaluate the feasibility of rapidly accruing 30 participants with recurrent metastatic head and neck squamous cell carcinoma for the development of patient derived xenographs (PDX) from fresh, real time biopsies in which sensitivity to \< 4 Ontario funded chemotherapeutic regimen will be tested. Written feedback to the primary oncologist will be provided.
2. There is also a curative intent cohort of 30 participants undergoing surgical resection with curative intent. These PDX models will undergo exome sequencing with written feedback.
3. Feasibility in both surgical and recurrent cohorts will be a measure of i) engraftment rate, ii) patient status at the time of drug testing completion and iii) rate of accrual.
1. Evaluate the feasibility of rapidly accruing 30 participants with recurrent metastatic head and neck squamous cell carcinoma for the development of patient derived xenographs (PDX) from fresh, real time biopsies in which sensitivity to \< 4 Ontario funded chemotherapeutic regimen will be tested. Written feedback to the primary oncologist will be provided.
2. There is also a curative intent cohort of 30 participants undergoing surgical resection with curative intent. These PDX models will undergo exome sequencing with written feedback.
3. Feasibility in both surgical and recurrent cohorts will be a measure of i) engraftment rate, ii) patient status at the time of drug testing completion and iii) rate of accrual.
Detailed Description:
Tumour samples from 30 participants with HNSCC that undergone curative surgery will be used to establish patient-derived xenografts (PDXs). These tumours will also undergo exome sequencing. This will provide a biobank of PDX models with available genomic information for future research projects. Another 30 participants with recurrent or metastatic HNSCC (RMHNSCC) will be recruited to this study. PDX models will be developed from these patient tumours, followed by genomic sequencing. PDX models are developed by transplanting small tumour pieces into immunocompromised mice. These mice are then treated with different available drugs for RMHNSCC at the discretion of their medical oncologist. These mice will be then followed up to examine the tumour response to treatments. When studied in clinic, PDX models have shown high correlation with patient response to the treatment. The PDX drug testing results will be provided to the treating medical oncologist to guide care at the oncologists discretion. Investigators' hope is that improved chemotherapy responses are observed with this strategy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: