Randomized trial of immediate treatment versus colposcopic followup for biopsy-proven cervical intraepithelial neoplasia (CIN) 1
| ISRCTN | ISRCTN91252554 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91252554 |
| Secondary identifying numbers | MCT-38135 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 12/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lorraine Elit
Scientific
Scientific
Juravinski Cancer Centre
Division of Gynecologic Oncology
699 Concession Street
Hamilton
L8V 5C2
Canada
| Phone | +1 905 389 5688 |
|---|---|
| laurie.elit@hrcc.on.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Randomized trial of immediate treatment versus colposcopic followup for biopsy-proven cervical intraepithelial neoplasia (CIN) 1 |
| Study objectives | The optimal management strategy for women with biopsy confirmed Cervical Intraepithelial Neoplasia 1 (CIN 1) is unclear. Our hypothesis is that a strategy of colposcopic follow up and treating progressive disease is as good as immediate treatment with Loop Electrosurgical Excision Procedure (LEEP). |
| Ethics approval(s) | Ethics approval received from the McMaster University Research Ethics Board in December 2004. |
| Health condition(s) or problem(s) studied | Preinvasive Cervical Disease |
| Intervention | 1. Colposcopic Follow up for 18 months 2. Immediate LEEP treatment Trial details received: 12 Sept 2005 |
| Intervention type | Other |
| Primary outcome measure | Progression to CIN 2 or worse within 18 months. |
| Secondary outcome measures | 1. Persistent CIN 1 at 18 months 2. Adverse events 3. Assess the following prognostic factors: persistent versus incident disease, lesion size, patients age, smoking, Human Papillomavirus (HPV) type and load |
| Overall study start date | 01/11/2000 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 884 |
| Total final enrolment | 415 |
| Key inclusion criteria | 1. Documented CIN 1 by histologic assessment as the highest grade lesion present 2. Lesion confined to the cervix and completely visualized 3. Be 16 years or older, female |
| Key exclusion criteria | Among patients satisfying the inclusion criteria the following will be excluding characteristics: 1. Index Pap smear showing CIN 2, 3 or cancer: 1.1. Index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia or malignancy requiring immediate investigation 1.2. Patients with previously identified CIN 1 by biopsy who are already in a surveillance program 2. Unsatisfactory colposcopic exam defined as inability to see the extent of the lesion in the endocervical canal or absence of a lesion on the ectocervix but endocervical curettage shows CIN 1 3. Pregnancy 4. Prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy 5. Prior gynecologic cancer 6. Prior pelvic radiation therapy 7. Inability to attend outpatient followup visits because of geographic inaccessibility 8. Other malignancies except non-melanoma skin cancer 9. Immunosuppression due to diseases such as Acquired Immune Deficiency Syndrome (AIDS), organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus 10. Cognitively impaired or otherwise unable to obtain written informed consent 11. Extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia 12. Colposcopically visible condyloma outside of the transformation zone 13. Known allergy to local analgesics 14. Clinically evident vaginitis must be treated and resolved prior to entry on the trial 15. Inability to read and respond in English 16. Failure to provide informed consent |
| Date of first enrolment | 01/11/2000 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Juravinski Cancer Centre
Hamilton
L8V 5C2
Canada
L8V 5C2
Canada
Sponsor information
McMaster University (Canada) - Faculty of Health Sciences
University/education
University/education
c/o Ms. Marie Townsend
Administrator, Research Programs
Office of the Associate Dean
1200 Main St. W., Room HSC-3N8
Hamilton
L8N 3Z5
Canada
| Phone | +1 905 525 9140 ext. 22465 |
|---|---|
| hsresadm@mcmaster.ca | |
| Website | http://www.mcmaster.ca/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38135)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/04/2011 | 12/04/2021 | Yes | No |
Editorial Notes
12/04/2021: Publication reference and total final enrolment added.
