Detecting HPV DNA in Anal and Cervical Cancers

Официальное название

Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy

Обзор

This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.

Вмешательства

• Лучевая терапия Radiation Treatment With or Without Chemotherapy
  Standard care radiation treatment.
• Другое 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.
• Диагностический тест 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.
• Диагностический тест 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.
• Другое 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).
• Диагностический тест 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.

Первичные конечные точки

• Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples [Срок оценки: 25 months]

Вторичные конечные точки (1)

• Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.
• Age ≥ 18 years
• Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy

Критерии исключения

• Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the
• Planned to undergo radiation therapy as an adjuvant or post-operative therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 2 центра

• University of Illinois at Chicago — Chicago
• University of Chicago — Chicago

Идентификаторы

NCT: NCT04857528 · IRB20-0410

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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