NL-OMON23864尚未招募不适用
A two-part (observational and intervention) study to explore disease characteristics of vulvar (pre)malignancies compared to healthy volunteers.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CHDR
- 入组人数
- 40
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Non-pregnant female subjects, 25-75 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 Day 0.
- •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 language.
- •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 screening:
- •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 inclusion.
- •Eligible LS patients must meet all of the following inclusion criteria at screening:
- •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 screening:
- •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 screening:
- •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 psoriasis.
- •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.
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