Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.

Learn more about:
Related Clinical Trial
Education, Immigration and HPV Vaccination: an Informational Randomized Trial Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years Serial MRI Scans During Radiation Therapy A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Cisplatin+Pembrolizumab+RT in Vulvar Cancer Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery MR-HIFU for Recurrent Gynaecological Cancer Pelvic Floor Disorders in Survivors of Gynecologic Malignancies Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life Paclitaxel Therapeutic Drug Monitoring in Cancer Patients Validation of a Nutrition Screening Tool A Survivorship Care Plan for Gynaecological Cancer Patients Self-Advocacy Serious Game in Advanced Cancer Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) Chemoradiation-Induced Nausea and Emesis: Quality of Life A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021) A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies ChemoFx® PRO – A Post-Market Data Collection Study Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer Image-Guided Gynecologic Brachytherapy Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer Topical Imiquimod in Treating Patients With Recurrent Paget’s Disease of the Vulva Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox. The Impact of the “WOMAN-PRO II Program” on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence CaptHPV : Validation of the Method “CaptHPV” for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers Effectiveness of an Individualized Symptom Education Program (ISEP) A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stage IV Vulvar Cancer Undergoing Surgery and Lymphadenectomy Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva Added-value of SPECT/CT in Patients Undergoing LM/SL for Gynecological Cancers Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer OCT-AF Imaging of Pre-cancers of Vulva and Cervix Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients. Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer Sentinel Node Extended in Squamous Cell Vulvar Cancer Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

Brief Title

Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.

Official Title

Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.

Brief Summary

      Almost half of all women will develop an HPV infection in their lifetime. While most
      infections are naturally asymptomatic or cleared by the immune system, some persist and can
      lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening
      regimens for these lesions are currently only in place for the cervix through regular Pap
      tests. These Pap tests usually involve an examination of the vulva -however, no screening
      procedures exist for anal cancer for women. Several studies have suggested that women with
      existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here
      the investigators propose a multi-center study which seeks to screen for and treat anal
      cancer in women over the age of 40 with vulvar lesions and a stable immune system. The
      investigators will achieve this through performing anal Pap smears on eligible women and
      conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with
      abnormal anal cells. With enough evidence, there may be an indication to establish regular
      anal cancer screening measures in this potentially underserved population.

      Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or
      VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and
      11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine
      anal screening regimens in Ontario and help shift health policy to treat this population.
    



Study Type

Interventional


Primary Outcome

Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer

Secondary Outcome

 Prevalence of AIN in women with VIN 2/3 or vulvar cancer

Condition

Vulvar Cancer

Intervention

Screening anal Pap smear - No high-resolution anoscopy

Study Arms / Comparison Groups

 Screening anal Pap Smear - Negative (75%)
Description:  All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

110

Start Date

February 1, 2021

Completion Date

February 1, 2023

Primary Completion Date

February 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Women age ≥ 40

          -  Previous diagnosis of VIN 2/3 or vulvar

        Exclusion Criteria:

          -  Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin,
             cervical cancer, or vulvar cancer

          -  Women who are HIV positive

          -  Women currently taking immunosuppressant medication

          -  Women who have had a previous hysterectomy
      

Gender

Female

Ages

40 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Danielle Vicus, MD, 4164805000, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03061435

Organization ID

GYNEOCC 3


Responsible Party

Sponsor-Investigator

Study Sponsor

Dr. Danielle Vicus


Study Sponsor

Danielle Vicus, MD, Principal Investigator, Odette Cancer Centre


Verification Date

May 2021