NL-OMON54913
Completed
Phase 4
A two-part (observational and intervention) study to explore disease characteristics of vulvar (pre)malignancies compared to healthy volunteers. - Deep phenotyping of vulvar (pre)malignant disease.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Non\-pregnant female subjects, 25\-95 years of age (inclusive); in general,
- •stable good health as per judgment of the investigator based upon the results
- •of a medical history, physical examination (BMI \* 30\) and vital signs.
- •2\. BMI of \* 30
- •3\. If female of childbearing potential, have a negative urine pregnancy test at
- •4\. Willing to give written informed consent and willing and able to comply with
- •the study protocol.
- •5\. Ability to communicate well with the investigator in the Dutch or English
- •6\. Subject is willing to undergo vulvar biopsies.
- •7\. Subject is willing to refrain from washing (including bathing, swimming,
Exclusion Criteria
- •1\. Significant, uncontrolled or unstable disease in any organ system as per
- •judgment of the investigator (regardless of association with the
- •immunosuppressing disorder/therapy), including but not limited to: psychiatric,
- •neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal,
- •endocrine, hematologic or respiratory disease.
- •2\. History of immunological abnormality (e.g., immune suppression) that may
- •interfere with study objectives, in the opinion of the investigator.
- •3\. Known infection requiring (topical or oral) antibiotic therapy within 28
- •days prior to Day 0;
- •4\. The use of any oral/systemic medication (e.g. immunomodulatory,
Outcomes
Primary Outcomes
Not specified
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