HPV Testing vs Colposcopy for Cervical Dysplasia

(CoHIPP Trial)

Recruiting in Montreal (>99 mi)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunosuppression, Planned hysterectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2253 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will compare HPV testing to the routine colposcopy in the follow-up of women treated for cervical high grade lesions. Women will be assigned randomly (by chance) after treatment of cervical pre-cancer to be either (1) followed-up by colposcopy, or (2) undergo HPV testing. Women found to have disease by either strategy will be offered re-treatment. For the next 2 years participants will undergo yearly, in depth, evaluation to assess the cervix for precancer. We will then be able to compare which of the 2 follow-up strategies worked best.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or certain corticosteroids, you may not be eligible to participate.

What data supports the effectiveness of the treatment high risk HPV DNA testing and routine colposcopy for cervical dysplasia?

Research shows that high-risk HPV testing is more sensitive than traditional methods for detecting serious cervical changes, and combining it with colposcopy can help identify women at risk more accurately. This approach can improve the management of cervical dysplasia by reducing unnecessary procedures and focusing on those who need further attention. ^{1 2 3 4 5}

Is HPV testing and colposcopy safe for humans?

Colposcopy is generally safe but can have some risks, such as affecting quality of life and causing sexual dysfunction. HPV testing is a common screening tool and is considered safe for human use. ^{6 7 8 9 10}

How does routine colposcopy differ from other treatments for cervical dysplasia?

Routine colposcopy is unique because it is a diagnostic procedure that visually examines the cervix to identify abnormal areas, unlike other treatments that may rely solely on cytology (cell study) or HPV testing. It is particularly valuable for confirming diagnoses and guiding management decisions in women with abnormal cervical screening results. ^{8 11 12 13 14}

Research Team

Marie-Hélène Mayrand, MD,PhD

Principal Investigator

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Eligibility Criteria

This trial is for women over 18 who have been treated for high-grade cervical lesions, understand English or French, and can sign the consent form. It's not for those planning a hysterectomy, on recent immunosuppressive therapy, with a history of cervical cancer treatment, or unlikely to follow the study plan.

Inclusion Criteria

I am a woman over the age of 18 (19 in specific regions).

I understand English or French.

I am being treated for a confirmed case of CIN II, III, or AIS.

Exclusion Criteria

I have not taken corticosteroids in the last two weeks.

I am currently receiving or have received a specific treatment.

I have not taken immunosuppressive drugs in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive treatment for high-grade cervical lesions

6 months

Follow-up

Participants undergo yearly evaluation to assess the cervix for precancer

2 years

Yearly in-depth evaluation

Diagnostic Assessment

Expert diagnostic assessment at 12 and 24 months

24 months

Treatment Details

Interventions

• high risk HPV DNA testing
• Routine colposcopy

Trial Overview The trial compares two methods to monitor women after treatment for cervical pre-cancer: routine colposcopy versus HPV DNA testing. Participants will be randomly assigned to one of these strategies and followed up yearly for 2 years to see which method is more effective.

Participant Groups

Group I: HPV testing Experimental Treatment 1 Intervention

Women randomized to this arm will undergo high risk HPV DNA testing using Hybrid Capture 2®.

Group II: Routine colposcopy Active Control 1 Intervention

Women will be followed in the colposcopy clinic as usual, with no standardized protocol, tests are left at the discretion of the treating physician, in order to document routine proactive. We will document all procedures (biopsies, endocervical curettage, cytology, etc) and their outcome.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Terry Fox Foundation

Collaborator

Trials

8

Recruited

4,400+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical performance of primary HPV screening cut-off for colposcopy referrals in HPV-vaccinated cohort: Observational study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Risk of high-grade cervical intra-epithelial neoplasia based on cytology and high-risk HPV testing at baseline and at 6-months. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Inclusion of HPV testing in routine cervical cancer screening for women above 29 years in Germany: results for 8466 patients. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating Colposcopy with Dynamic Spectral Imaging During Routine Practice at Five Colposcopy Clinics in Wales: Clinical Performance. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Comparison of HPV Testing and Colposcopy in Detecting Cervical Dysplasia in Patients With Cytological Abnormalities. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Baseline colposcopic findings in women entering studies on female vaginal products. [2008]

7. England pubmed.ncbi.nlm.nih.gov

Incidence of cervical intraepithelial neoplasia grade 2 or worse in colposcopy-negative/human papillomavirus-positive women with low-grade cytological abnormalities. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The future role for colposcopy in Europe. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse outcomes after colposcopy. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Abnormal cervical cytology in pregnancy: a 17-year experience. [2009]

11. France pubmed.ncbi.nlm.nih.gov

[Colposcopy: the value of HPV testing in clinical practice]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Role of colposcopy in the management of women with abnormal cytology. [2022]

13. England pubmed.ncbi.nlm.nih.gov

The value of human papillomavirus testing in the colposcopy clinic. [2006]

14. England pubmed.ncbi.nlm.nih.gov

Reflex Human Papillomavirus Test Results as an Option for the Management of Korean Women With Atypical Squamous Cells Cannot Exclude High-Grade Squamous Intraepithelial Lesion. [2022]