Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma in Situ

Uterine Cervical Dysplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Group 1, pt 0-20: daily application of 5 grams (with applicator) for 1 month. Followed by weekly applications (5 grams withapplicator) for 5 months.

Group 2, pt 20-40: daily application of 5 grams (with applicator) for 3 months. Then weekly applications (5 grams with applicator) for3 months.

Group 3, pt 40-60: daily application of 5 grams (with applicator) for 6 months

daily application of 5 grams (with applicator)

Medical grade honey formulation (MGH) (L-Mesitran®)

Jordy Mongula, dr.

The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase inthe normalization of CIN II lesions compared to expectant management.

In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standard guidelines between a LLETZ, imiquimod or expectant management. 1 Patients choosing for expectant management will be asked to participate in the study and treatment with medical grade honey. Patients choosing imiquimod or LLETZ will be asked for the control arm. Follow-up assessment takes place in accordance with the national guideline (first check-up is after 6 months). 1 In addition, swabs for vaginal microbiota analysis will be taken at 0 and 6 months. Immunohistochemical stainings for the local immune infiltrate will be performed on biopsies taken during regular colposcopy at t=0. This exploratory study assesses the potential effect of honey, the optimal dosage and provides insight into its mechanisms of action.

In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standardguidelines between a LLETZ, imiquimod or expectant management. Patients choosing for expectant management will be asked toparticipate in the study and treatment with medical grade honey. Patients choosing imiquimod or LLETZ will be asked for the controlarm. Follow-up assessment takes place in accordance with the national guideline (first check-up is after 6 months). In addition,swabs for vaginal microbiota analysis will be taken at 0 and 6 months. Immunohistochemical stainings for the local immune infiltratewill be performed on biopsies taken during regular colposcopy at t=0. This exploratory study assesses the potential effect of honey,the optimal dosage and provides insight into its mechanisms of action.

Effect of Honey For CIN II

The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II

The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus

normalization of cytology (KOPAC) (depending on NVOG/RIVM flowchart).

species specific and diversity analysis, changes due to Honey and relationship with the other outcomes measures

Zuyderland Medisch Centrum

Infections

Symptoms and General Pathology

Papilloma

Uterine Cervical Neoplasms

Communicable Diseases

Virus Diseases

Papillomavirus Infections

Neoplasms, Squamous Cell

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Women 30 years of age or older coming for routine cervical screening who tested triple negative at baseline with the interventions: Thinprep® LBC, HR HC2® HPV DNA and APTIMA® HPV Assay

Women who tested positive in any of the tests Thinprep® LBC, HR HC2® HPV DNA or APTIMA® HPV Assay will undergo colposcopy and be followed up over a ten year period and subjects who tested positive during the follow up assessment will be followed up over a 5 year period on a yearly basis

Thinprep® LBC

APTIMA® HPV Assay

HR HC2® HPV DNA

Colposcopy

Thomas Iftner, Prof.

To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the APTIMA® HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of HPV infection and high-grade CIN lesions in a screening population of women 30 years of age or older in Germany.

The study is conducted in the areas of Tuebingen, Freiburg and Saarbruecken in Germany. In total, 10.000 ThinPrep® LBC cervical samples were collected from June 2009 to May 2012. Liquid based cytology (LBC) was performed by a central laboratory in Saarbruecken. Human papilloma virus (HPV) testing with the HR HPV HC2® test and APTIMA® HPV Assay were performed at the Section of Experimental Virology, Institute of Medical Virology, University Clinic of Tuebingen, Germany (UKT).

Within a follow-up phase women who tested positive in any test at baseline will be monitored over a period of 10 years.

Study close out visit: In addition, approximately 5 years after baseline ThinPrep® LBC cervical samples will be collected from a random sample of 4000 study participants who tested triple negative at baseline for determination of the longitudinal negative predictive value (NPV) and HPV related disease after a 5 year period. Women who tested positive in any test will undergo colposcopy.

liquid based cytology LBC Specimens (ThinPrep® Pap Test)

Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens

Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HPV HC2® Test in Women 30 Years of Age or Older Using LBC ThinPrep® Pap Test Specimens

In triple negative study participants (HR HPV HC2® test and APTIMA® HPV and LBC) at baseline the longitudinal negative predictive value of HPV infections will be determined after a 5 year period.

In triple negative study participants at baseline the cumulative risk of HPV infection will be determined after a 5 year period.

Linear regression models will be used for determination of cross sectional associations between HR HPV Infection and LBC diagnosis.

Analysis of study results at baseline and follow-up visits. Calculation of relative risks of cervical disease for women who are positive for LBC, HC2® and/or APTIMA® test compared to those being negative for any of the three tests at the baseline visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Honey For CIN II	NCT06219018	Cervical Intrae... High Risk Human...	Medical grade h...	18 Years - 40 Years	Zuyderland Medisch Centrum
Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens	NCT02634190	Human Papilloma...	Thinprep® LBC APTIMA® HPV Ass... HR HC2® HPV DNA Colposcopy	30 Years - 60 Years	Hologic Deutschland GmbH
Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens	NCT02634190	Human Papilloma...	Thinprep® LBC APTIMA® HPV Ass... HR HC2® HPV DNA Colposcopy	30 Years - 60 Years	Hologic Deutschland GmbH

Spots Global Cancer Trial Database for high risk human papillomavirus