Use of CNB FPPE samples to determine sample input requirements
Research type
Research Study
Full title
A non-interventional, retrospective study for the testing of RNA extraction yields using the QIAGEN RNeasy DSP FFPE Kit (Cat. No. 73604) from Resection and Core Needle Biopsy (CNB) samples that have been Formalin Fixed and Paraffin Embedded (FFPE). Resection samples are derived from patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN), cervical cancer, vaginal cancer, vulvar cancer, anal cancer and penile cancer, and CNB samples are derived from SCCHN. CNB samples will be provided by a pharmaceutical partner from patients that have participated in BMS clinical trials (CA209-714 and CA025-003) and their samples have been stored for future purposes other than the clinical trial in which the samples were collected. The results from this study will be used to determine the optimum input of CNB samples to obtain a sufficient RNA yield for assessment of HPV 16 E7 expression using the therascreen HPV RNA RGQ RT-PCR Kit, which is currently in development.
IRAS ID
301179
Contact name
K S Webb
Contact email
Sponsor organisation
QIAGEN
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary:
The Sample Processing Feasibility study demonstrated a minimum tissue surface area for samples to be used with the therascreen HPV RNA RT-PCR Kit, and provided the optimsed RNA extraction parameters to be taken forward into future development work.Bristol Myers Squibb (BMS) have partnered with QIAGEN to develop an investigational use only diagnostic test, the therascreen HPV RNA RGQ RT-PCR Kit, that will detect if HPV 16 E7 mRNA is present or not in FFPE tumor samples from patients who have Squamous Cell Carcinoma of the Head and Neck (SCCHN), cervical cancer, vulvar cancer, vagina cancer, anal cancer and penile cancer. If HPV 16 E7 mRNA is detected, the patient may be eligible for enrollment in a Bristol Myers Squibb (BMS) clinical trial of an engineered T cell therapy (BMS-986422), which may be a better treatment option than the current standard of care. BMS-986422 consists of engineered T cells targeting HPV16 E7 in patients whose tumors are positive for the expression of HPV 16 E7 mRNA and have a positive HLA-A*02:01 blood test result.
This is a feasibility study is designed to determine the optimum input of resection and CNB samples to obtain a suitable RNA yield by extraction of the samples with the QIAGEN RNeasy DSP FFPE Kit, for use with the therascreen HPV RNA RGQ RT-PCR Kit. The CNB clinical samples will be provided by BMS from patients with SCCHN that have participated in previous clinical trials and stored by BMS for future use. Consent is in place to test these samples in future research. The samples will be imported as FFPE slides from the USA in anonymized form and material transfer is covered by a contract termed ‘Initiation Agreement Between CELGENE Corporation (“CELGENE”) and QIAGEN Manchester Limited (QIAGEN) relating to Companion and/or Complementary Diagnostics development’ in place between BMS and QIAGEN. NOTE: CELGENE have been acquired by Bristol Myers Squibb since the contract was signed and the contract mentioned above remains valid.Summary of Research:
The Sample Processing Feasibility study demonstrated a minimum tissue surface area for samples to be used with the therascreen HPV RNA RT-PCR Kit, and provided the optimsed RNA extraction parameters to be taken forward into future development work.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0112
Date of REC Opinion
16 Jun 2021
REC opinion
Favourable Opinion