Detecting HPV DNA in Anal and Cervical Cancers
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|ClinicalTrials.gov Identifier: NCT04857528|
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : June 10, 2021
|Condition or disease||Intervention/treatment|
|Cervical Cancer Anal Cancer HPV-Related Anal Squamous Cell Carcinoma HPV-Related Cervical Carcinoma HPV-Related Carcinoma Uterine Cervical Cancer||Radiation: Radiation Treatment With or Without Chemotherapy Other: Blood Sample Collection Diagnostic Test: HPV Genotyping (HPV DNA Test) Diagnostic Test: Testing Archival Tumor Tissue Other: Physical Exam Diagnostic Test: Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy|
|Actual Study Start Date :||October 6, 2020|
|Estimated Primary Completion Date :||November 15, 2023|
|Estimated Study Completion Date :||November 15, 2023|
Retrospective (Participants Who Have Already Been Treated for HPV-Related Cancer Before Study)
This group will use medical records from participants who have already received chemoradiation for their HPV-related anal or cervical cancer at a time before this study started. Because they have already received treatment, these participants will provide previous blood/tumor tissue samples that contain detectable HPV DNA as well as at least one post-treatment sample that their doctor collected before the study. Data from these previously collected samples will be compared to current samples from participants who are actively enrolled in this study in present day (chart review).
Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study)
This group is for participants who plan to receive radiation treatment (with or without chemotherapy) for their HPV-related anal or cervical cancer during the time this study will be conducted. Participants in this group will sign a consent form allowing researchers to collect their blood samples and analyze/compare them to the samples from the retrospective group of participants.
Radiation: Radiation Treatment With or Without Chemotherapy
Standard care radiation treatment.
Other: Blood Sample Collection
Researchers will collect blood samples from participants before, during and after radiation treatment. Approximately 6 teaspoons of blood will be collected each time blood is drawn.
Diagnostic Test: HPV Genotyping (HPV DNA Test)
A test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.
Diagnostic Test: Testing Archival Tumor Tissue
Tumor tissue will be tested in a lab for all cervical cancer participants and some participants with anal cancer as assessed by the lead study doctor. This tumor tissue sample will be from a previous biopsy that the participant received before the study per standard care; no new biopsy will be required for this study.
Other: Physical Exam
A physical exam will be given 12 months after radiation treatment. This physical exam may also include an anoscopy (a procedure to examine the anus using a device inserted into the anus) or sigmoidoscopy (a procedure that looks at the rectum and lower part of the colon using a device inserted into the anus).
Diagnostic Test: Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)
Tests that use computers and/or rotating x-rays to scan/create images of the body.
- Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples [ Time Frame: 25 months ]The rate of participants who have detectable HPV DNA in their blood and tumor samples as assessed by analyzing blood/ tumor tissue samples using Polymerase chain reaction (PCR) tests.
- Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months [ Time Frame: 24 months ]The accuracy of post-treatment HPV DNA levels in predicting cancer recurrence at 24 months after treatment. This accuracy will be assessed using statistical calculations incorporating data from the participant's HPV DNA detection test results and clinical records.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857528
|Contact: Christina Son, MDfirstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Clinical Trials Intake 855-702-8222 email@example.com|
|Principal Investigator: Christina Son, MD|
|Principal Investigator:||Christina Son, MD||University of Chicago|