Evaluation of a Novel Microsatellite Instability Panel in Head and Neck Squamous Cell Carcinoma
D
Diane Chen
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
200 participants needed
1 Location
Overview
What is this study about?
The goal of this study is to validate polymerase chain reaction (PCR)-based method of detecting microsatellite instability in solid tumors with emphasis on head and neck malignancies through comparison with immunohistochemical (IHC) analysis of mismatch repair (MMR) proteins.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Description
What will happen during this study?
- We will identify, with a search in the anatomic pathology information system CoPath, tumor specimens with adequate residual formalin-fixed, paraffin-embedded archival tissue (paraffin blocks) including normal comparison tissue from adult patients.
- Patients' electronic medical records of tissue specimens may need to be reviewed for appropriateness of diagnosis of primary head and neck squamous cell carcinoma.
- Specimens will be de-identified prior to immunohistochemical (IHC) staining and PCR testing, and no identifiable patient information will be included in any data collection or analyses.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Squamous Cell Carcinoma
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria
• Archival paraffin-embedded tissue from adult patients ages 18 and older carrying diagnosis of squamous cell carcinoma arising from the head and neck
• Head and neck subsites include: oral cavity, oropharynx, sinonasal, salivary gland, cutaneous skin of scalp, face, ears, nose, lips, neck, and thyroid
Exclusion Criteria
• Metastatic lesions from non-primary head and neck cancers (i.e. breast cancer, renal cell)
• Lymphoma or other lymphoproliferative disorders
• Archival paraffin-embedded tissue from adult patients ages 18 and older carrying diagnosis of squamous cell carcinoma arising from the head and neck
• Head and neck subsites include: oral cavity, oropharynx, sinonasal, salivary gland, cutaneous skin of scalp, face, ears, nose, lips, neck, and thyroid
Exclusion Criteria
• Metastatic lesions from non-primary head and neck cancers (i.e. breast cancer, renal cell)
• Lymphoma or other lymphoproliferative disorders
Updated on
01 Aug 2024.
Study ID: OTHN-IIR-MICROSATELLITE, 20462
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