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

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ClinicalTrials.gov Identifier: NCT03061435
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Danielle Vicus, Sunnybrook Health Sciences Centre

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.


Condition or disease Intervention/treatment Phase
Vulvar Cancer Cervical Cancer Vulvar Dysplasia Cervical Dysplasia Anal Cancer Anal Dysplasia HPV-Related Anal Squamous Cell Carcinoma Procedure: Screening anal Pap smear - No high-resolution anoscopy Procedure: Screening anal Pap smear - High-resolution anoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Screening anal Pap Smear - Negative (75%)
All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.
Procedure: Screening anal Pap smear - No high-resolution anoscopy
75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy

Screening anal Pap Smear - Negative (25%)
All patients will receive an anal Pap test. Remaining 25% of patients will proceed to high-resolution anoscopy (HRA) clinic to assess the negative predictive rate of HRA.
Procedure: Screening anal Pap smear - High-resolution anoscopy
25% of patients with negative cytology on their anal Pap smear will receive high-resolution anoscopy. All patients with positive (abnormal) cytology on their anal Pap smear will receive high-resolution anoscopy.

Screening anal Pap Smear - Positive
All patients will receive an anal Pap test. Any patient with abnormal cytology on their Pap test will be referred to HRA clinic for management. This includes potential biopsy and treatment.
Procedure: Screening anal Pap smear - High-resolution anoscopy
25% of patients with negative cytology on their anal Pap smear will receive high-resolution anoscopy. All patients with positive (abnormal) cytology on their anal Pap smear will receive high-resolution anoscopy.




Primary Outcome Measures :
  1. Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer [ Time Frame: 6 months to 1 year ]

Secondary Outcome Measures :
  1. Prevalence of AIN in women with VIN 2/3 or vulvar cancer [ Time Frame: 6 months to 1 year ]
  2. Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN [ Time Frame: 6 months to 1 year ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061435


Contacts
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Contact: Sasha Manohar, BSc 4164805000 ext 7387 sasha.manohar@sunnybrook.ca
Contact: Amanda Fonseca, BSc 4164805000 ext 89828 amanda.fonseca@sunnybrook.ca

Sponsors and Collaborators
Dr. Danielle Vicus
Investigators
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Principal Investigator: Danielle Vicus, MD Odette Cancer Centre

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Responsible Party: Dr. Danielle Vicus, Dr. Danielle Vicus, MD, MSc, FRCSC, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03061435     History of Changes
Other Study ID Numbers: GYNEOCC 3
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Danielle Vicus, Sunnybrook Health Sciences Centre:
Vulvar Cancer
Cervical Cancer
Vulvar Dysplasia
Cervical Dysplasia
Anal Cancer
Anal Dysplasia
HPV

Additional relevant MeSH terms:
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Anus Diseases
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Hyperplasia
Anus Neoplasms
Vulvar Neoplasms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases