A two-part (observational and intervention) study to explore disease characteristics of vulvar (pre)malignancies compared to healthy volunteers.
- Conditions
- vulvar (pre)malignanciesvulvar cancers1003859410014982
- Registration Number
- NL-OMON54913
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Punch biopsies: histology (e.g. H&E and HPV typing), IHC (e.g. p16 and p53),<br /><br>mRNA extraction<br /><br>* Vulvar pH*<br /><br>* Hormonal status (FSH, LS, estrogen)<br /><br>* DermaToolbox:<br /><br>- 2D photography* (photo documentation)<br /><br>- 3D photography* (lesion dimensions)\ - Dermoscopy* (erythema + roughness<br /><br>scores)<br /><br>- Optical Coherence Tomography* (skin morphology, skin layer thickness, blood<br /><br>perfusion)<br /><br>- Confocal Microscopy* (skin morphology)<br /><br>- Ultrasonography* (skin morphology, skin layer thickness, tumour penetration<br /><br>up to 4cm)<br /><br>- Trans Epidermal Water Loss* (skin barrier function)<br /><br>* Clinical scores (e.g. Günthert, RECIST, PROVOKE)<br /><br>* Patient reported outcomes* (this may include, but is not limited to: NRS<br /><br>pruritus, NRS burning sensation, NRS pain, sleeplessness QoL, patient<br /><br>satisfaction scores of imaging tools)</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Vulvar, vaginal and anal swabs* for microbiome</p><br>