NL-OMON54913已完成4 期
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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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,
- •showering and excessive sweating) the vulva counting from midnight of every
- •study visit day.
- •8. Subject is willing to refrain from application of products (e.g. ointments,
- •crème or wash) on the vulva 24 hours prior to every study visit day.
- •9. Subject is willing to refrain from sexual intercourse less than 24 hours
- •prior to every study visit.
- •10. Subject is willing to refrain from shaving, waxing or other hair removing
- •treatments in the perineal area in the 24 hours prior to every study visit.
- •11. Willing to refrain from any active treatment for vulvar HSIL and LS as from
- •14 days prior to Day 0.
- •Eligible HSIL patients must meet all of the following inclusion criteria at
- •12. At least one sharply marginated lesion (plaque) that can be accurately
- •measured (using RECIST criteria), in at least one dimension with a smallest
- •diameter of *15 mm, with confirmed HSIL diagnosis by histologic confirmation.
- •This histologic diagnosis does not necessarily have to be performed close to
- •Eligible LS patients must meet all of the following inclusion criteria at
- •13. Clinically and/or histologically diagnosed with LS and under topical
- •treatment with topical corticosteroids or willing to start topical steroid
- •treatment during study participation.
- •Eligible VSCC patients must meet all of the following inclusion criteria at
- •14. Histologically confirmed primary or local recurrent VSCC.
排除标准
- •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,
- •immunosuppressive, acetylsalicylic acid) within 28 days prior to Day 0, if the
- •investigator judges that it may interfere with the study objectives. The use of
- •paracetamol (up to 4 g/day) is allowed;
- •5. Pregnant, a positive pregnancy test, intending to become pregnant, or
- •breastfeeding;
- •6. Self-reported: (a) immunocompromised state, (b) sexually transmitted
- •disease, (c) AIDS and/or (d) hepatitis.
- •7. Have any current and / or recurrent clinically significant or subject
- •reported skin condition in the vulvar area other than the (absence of) vulvar
- •disease wherefore subject is included in the study.
- •Eligible vulvar patients must meet none of the following exclusion criteria at
- •8. Have any current relevant (inflammatory) skin infections in the treatment
- •area other than the observational disease (vulvar LS, vulvar HSIL of VSCC),
- •inclusively, but not limited to atopic dermatitis, herpes, candidiasis or
- •9. Have used or received any topical vulvar HSIL treatment, laser therapy or
- •surgery in the anogenital area within 28 days prior to Day 0
- •10. Have used or received any topical corticosteroids or other topical immune
- •suppressive treatment for LS within 14 days prior to Day 0
- •11. Have used or received chemo-or radiotherapy or surgery in the anogenital
- •area within 3 months prior to enrolment.
研究者
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