Improving Diagnostics in Cervical Dysplasia

NCT05283421 | Recruiting DMC

• 1 other identifier: 1-23-456
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical cancer is the fourth most common cancer in women worldwide. It is caused by an infection with human papillomavirus (HPV). A persistent infection with HPV is associated with increased risk of precancerous lesions, which may further develop into cervical cancer. To reduce the disease burden, accurate and timely diagnosis of cervical precancerous lesions are crucial. To identify cervical precancerous lesions, women are referred to colposcopy, which is the most important diagnostic tools to detect cervical precancerous lesions. It allows close visualization of the cervix in order to collect biopsies in the area called transformation zone (TZ), which is where precancerous lesions develop. It is essential for the physician to identify the TZ during colposcopy in order to obtain correct diagnosis. For women aged ≥50 this is often a challenge as TZ naturally with age, will retract further into the cervical canal, making the area for sampling invisible, and thereby the colposcopy inadequate. Consequently, this increases the risk of developing cancer due to diagnostic delay, and the risk of several colposcopy examinations or overtreatment (cone biopsy), before a final diagnosis is achieved. Few studies suggest that pretreatment with local vaginal estrogen prior to colposcopy may improve visualization of the TZ. Thereby, obtaining more accurate biopsies from the cervix, and thus making a more accurate and timely diagnosis in the first outpatient visit. The primary purpose of this study is to evaluate pre-diagnostic treatment with estrogen to improve the diagnosis of women with cervical precancerous lesions, in order to prevent cervical cancer. The study ia s randomized controlled double-blind multicenter study. The investigators will use information from Danish National Patient registry, and data from the Danish Pathology Data Bank. Enrollment will take place at the Departments of Gynecology in Denmark. Eligible women aged ≥ 50 years will be randomized 1:1 to receive local vaginal estrogen or placebo prior to the colposcopic examination. The investigators believe the results will provide the prerequisite for obtaining correct diagnosis, and thereby provide basis for choosing the right individualized examination- and treatment plan. The results will also contribute with important knowledge, that may help reduce the incidence and mortality rate of cervical cancer.

Conditions

Cervical Cancer

Keywords

Colposcopy; Estrogen

Outcome Measures

Primary Outcomes (2)

• Scoring of the visibility of the Squamous columnar junction (SCJ)

  Scoring of the visibility of the SCJ by the colposcopist as visible (TZ1), partly visible (TZ2) or not visible (TZ3) during colposcopic examination.

  through study completion, an average of 1 year

• Number of patients with representation of the transformation zone in the cervical biopsies.

  Representation of the transformation zone in the cervical biopsies from all patients, evaluating from the pathology registration. When the transformation zone is present, the biopsies have been taken in the correct location of the cervix.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• The patients' report on possible side effects during pretreatment through questionnaire

  through study completion, an average of 1 year

• Evaluate the proportion of CIN2+ found in biopsies.

  1 month after the biopsy was collected at colposcopy

• diagnostic conus.

  1 month after the biopsy was collected

• Evaluation of biopsies

  1 month after the biopsy was collected at colposcopy

Study Arms (2)

Active estrogen

ACTIVE COMPARATOR

Will receive pretreatment with vaginal application of estrogen 30 microgram (three tablets) once a day for 14 days.

Diagnostic Test: Estrogen

Placebo

PLACEBO COMPARATOR

Will receive pretreatment with vaginal application with no estrogen (three tablets) once a day for 14 days.

Diagnostic Test: Placebo

Interventions

Estrogen DIAGNOSTIC_TEST

Women will receive active estrogen treatment or placebo prior to the colposcopic examination

Also known as: Vagifem

Active estrogen

Placebo DIAGNOSTIC_TEST

Women will receive active estrogen treatment or placebo prior to the colposcopic examination

Placebo

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: The investigators evaluate diagnostic for cervical precancerous lesions
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal (defined as no bleeding ≥1 year) women referred for colposcopy aged ≥ 50 years.
• Women referred for colposcopy due to a positive HPV test and/or an abnormal cervical cytology.
• Women referred for colposcopy due to previous abnormal cervical histology with minimum 6. months since last colposcopy with biopsies.

You may not qualify if:

• Use of estrogen within the last 3 months regardless of administration form.
• previous cervical radiotherapy, cervical amputation and/or cone biopsy
• pregnancy

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Gynecology and Obstetrics

Randers, 8930, Denmark

RECRUITING

Related Publications (1)

• Bertelsen VM, Tranberg M, Petersen LK, Booth B, Bor P. Improving diagnostic of cervical dysplasia among postmenopausal women aged >/=50 years using local vaginal oestrogen treatment prior to colposcopy: study protocol for a multicentre randomised controlled trial (the IDEAL study). BMJ Open. 2024 Jun 23;14(6):e082833. doi: 10.1136/bmjopen-2023-082833.

  PMID: 38910002 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Marianne Esbjerg, GCP-investigator

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vibe M Bertelsen, MD, PhD student

CONTACT

+4578421069; vibebert@rm.dk

Isil Pinar Bor, Ass. professor

CONTACT

+4578421069; isipinbo@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: A randomization code will be made and given to the hospital pharmacy who will be packing and blind the tablets for the study. The study medicine will be sent to the women with the same/equal etiquette. At the gynecological examination, the colposcopist will not know which study arm the woman is in.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled double blind multicenter study

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 17, 2022
• Study Start: August 23, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 16, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)