Studying Biomarkers in Diagnosing Cervical Lesions in Patients with Abnormal Cervical Cells
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-001737
NCT ID: NCT00892866
Sponsor Protocol Number: GOG-0237
About this study
This clinical trial is studying biomarkers in diagnosing cervical lesions in patients with abnormal cervical cells. Studying biomarkers in abnormal cervical cells may improve the ability to find cervical lesions and plan effective treatment.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with a cytologic diagnosis of AGC (AGC, AEC, AEmC) or a cytologic/histologic diagnosis of AIS documented within the last 6 months who can wait at least one week after the AGC or AIS diagnosis to have an LBC specimen collected (within two weeks of registration) and then receive any other intervention.
- Patients with positive HPV results who are willing to undergo a complete histologic examination of the uterus and cervix, including the cervical transformation zone, within 6 months of the AGC or AIS diagnosis (histologic examination includes a LEEP, LETZ, excisional cone biopsy, or hysterectomy).
- Patients who are 18 years of age or older.
- Patients must have signed an approved informed consent and authorization permitting release of personal health information.
Exclusion Criteria:
- Patients under 18 years of age.
- Patients who have had a hysterectomy.
- Patients with a history of cancer of the endometrium, vagina, or cervix.
- Patients who have previously been treated, or are currently being treated with radiation therapy or chemotherapy for vaginal or cervical cancer.
- Patients who are known to be HIV-positive, as these patients often have disease that is highly variable and aggressive resulting in rapid changes.
- Patients who are pregnant and thought to be at risk for excessive bleeding or preterm labor if a cone biopsy is performed.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Andrea Wahner Hendrickson, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available