HPV Testing vs Colposcopy for Cervical Dysplasia

(CoHIPP Trial)

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates two follow-up methods after treatment for cervical pre-cancer: high-risk HPV DNA testing and the usual colposcopy (a close-up exam of the cervix with a special scope). The goal is to determine which method better detects any remaining or returning pre-cancerous changes. Women treated for certain types of cervical pre-cancer who speak English or French may qualify. Participants will either undergo regular colposcopies or receive HPV tests for two years to assess which approach is more effective. As an unphased trial, this study allows participants to contribute to important research that could enhance follow-up care for cervical pre-cancer.

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 prior data suggests that these follow-up strategies are safe for women treated for cervical high grade lesions?

Research shows that HPV testing safely checks for cervical health issues. Studies have found that high-risk HPV DNA tests can detect serious cervical changes earlier than other methods, potentially catching problems sooner. Importantly, the FDA has approved HPV testing for cervical screening, confirming it meets safety standards.

While HPV testing might identify some infections that don't lead to cancer, it generally maintains a good safety record. No major safety concerns have been reported in the reviewed sources.

This trial compares HPV testing to routine colposcopy, a standard procedure in cervical care. The researchers aim to determine which method is better for follow-up care after treatment for cervical pre-cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of HPV testing compared to routine colposcopy for detecting cervical dysplasia. Unlike the standard approach of colposcopy, which involves direct examination of the cervix and possible biopsies, HPV testing uses high risk HPV DNA testing through a method known as Hybrid Capture 2®. This approach could potentially offer a less invasive, more standardized, and quicker method for identifying at-risk patients. By focusing on the presence of high-risk HPV strains, researchers hope to improve early detection and streamline the process, possibly leading to better patient outcomes and reduced reliance on more invasive procedures.

What evidence suggests that this trial's follow-up strategies could be effective for cervical dysplasia?

This trial will compare high-risk human papillomavirus (HPV) DNA testing with routine colposcopy for cervical dysplasia. Studies have shown that testing for high-risk HPV effectively screens for cervical cancer, outperforming traditional methods in detecting early signs of cervical issues. Research indicates that using HPV testing for screening can significantly reduce the risk of developing cervical cancer. Known for its higher sensitivity, this testing excels at early detection of potential issues. It has proven more successful in identifying cervical pre-cancer and cancer than methods like cytology, which involves examining cells under a microscope. ^{6 7 8 9 10}

Who Is on the Research Team?

Marie-Hélène Mayrand, MD,PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

There is a strong probability that the participant will not follow the procedures of study, will not come to its appointment, or plans a delocalization throughout study.

I am currently receiving or have received a specific treatment.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5716831/

Performance of high-risk human papillomavirus DNA testing ... A modelling study in China18 found that one-time screening at age 35 years would reduce lifetime cervical cancer risk by 15–28%.

2. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2774442

Effectiveness of High-risk Human Papillomavirus Testing ... Testing for high-risk human papillomavirus (hrHPV) has been proven to be effective in screening for cervical cancer. Large prospective trials ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.14482

High‐risk HPV testing vs liquid‐based cytology for cervical ... Cervical cancer screening by cytology has successfully decreased cervical cancer incidence and mortality. This decline results from increased ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386653222000981

Clinical performance of DNA and RNA based HPV tests for ... High-risk human papillomavirus (hrHPV) based cervical screening has proved to be more effective at identifying cervical intraepithelial neoplasia (CIN) and ...

5. journals.asm.org journals.asm.org/doi/10.1128/jcm.00181-12

Comparison of Seven Tests for High-Grade Cervical ... High-risk human papillomavirus (HPV) DNA/RNA testing provides higher sensitivity but lower specificity than cytology for the identification of high-grade ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8881993/

Screening for Cervical Cancer - PMC Testing using HPV assays at 5-year intervals results in a lower risk of cancer and precancer than cytology testing at 3-year intervals. Sequential negative HPV ...

7. acog.org acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical-cancer-screening-guidelines

Updated Cervical Cancer Screening Guidelines Primary hrHPV testing uses high-risk HPV testing alone (no cytology) with a test that is approved by the U.S. Food and Drug Administration (FDA) ...

8. cdc.gov cdc.gov/std/treatment-guidelines/hpv-cancer.htm

Human Papillomavirus (HPV) Infection - STI Treatment ... Cervical cancer can be prevented with regular screening tests, like the Pap test (cytology) and HPV tests. Those at average risk should start ...

9. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening

Recommendation: Cervical Cancer: Screening Overall, the 4 trials found that hrHPV testing alone led to an increase in the rate of CIN 3+ detection compared with cytology alone in the ...

10. cancer.gov cancer.gov/types/cervical/hp/cervical-screening-pdq

Cervical Cancer Screening (PDQ®) - NCI Screening With the HPV DNA Test: Harms. Based on solid evidence, HPV testing identifies numerous infections that will not lead to cervical ...