A Study to Evaluate Immunotherapy and Ovarian Function Among Pre-menopausal Melanoma Survivors
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: 20-010873
Sponsor Protocol Number: 20-010873
About this study
The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.
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:
Cohort 1
- Women 45 or under diagnosed with melanoma (Stage IIB/C or above), 1-5 years from diagnosis, either received immunotherapy with anti-PD1 agent (n=20), or received no immunotherapy (n=20).
Cohort 2
- Women 45 or under diagnosed with melanoma and plan to undergo immunotherapy with anti-PD1 agent (n=20).
Exclusion Criteria:
- Women under 18 years of age.
Eligibility last updated 7/25/23. Questions regarding updates should be directed to the study team contact.
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 Zaraq Khan, M.B.B.S. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available