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| [ Print-friendly version ] |
| Randomized trial of immediate treatment versus colposcopic followup for biopsy proven cervical intraepithelial neoplasia (CIN) 1 |
| ISRCTN | ISRCTN91252554 |
| ClinicalTrials.gov identifier | |
| Public title | Randomized trial of immediate treatment versus colposcopic followup for biopsy proven cervical intraepithelial neoplasia (CIN) 1 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | MCT-38135 |
| Study hypothesis | 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). |
| Lay summary | |
| Ethics approval | Ethics approval received from the McMaster University Research Ethics Board in December 2004. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Preinvasive Cervical Disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/11/2000 |
| Anticipated end date | 30/09/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 884 |
| Interventions |
1. Colposcopic Follow up for 18 months
2. Immediate LEEP treatment Trial details received: 12 Sept 2005 |
| Primary outcome measure(s) | Progression to CIN 2 or worse within 18 months. |
| Secondary outcome measure(s) |
1. Persistent CIN 1 at 18 months
2. Adverse events 3. Assess the following prognostic factors: persistent versus incident disease, lesion size, patient’s age, smoking, Human Papillomavirus (HPV) type and load |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38135) |
| Trial website | |
| Publications | |
| Contact name | Dr Lorraine Elit |
| Address |
Juravinski Cancer Centre
Division of Gynecologic Oncology 699 Concession Street |
| City/town | Hamilton |
| Zip/Postcode | L8V 5C2 |
| Country | Canada |
| Tel | +1 905 389 5688 |
| Fax | +1 905 575 6343 |
| laurie.elit@hrcc.on.ca | |
| Sponsor | McMaster University (Canada) - Faculty of Health Sciences |
| Address |
c/o Ms. Marie Townsend
Administrator, Research Programs Office of the Associate Dean 1200 Main St. W., Room HSC-3N8 |
| City/town | Hamilton |
| Zip/Postcode | L8N 3Z5 |
| Country | Canada |
| Tel | +1 905 525 9140 ext. 22465 |
| Fax | +1 905 528 8539 |
| hsresadm@mcmaster.ca | |
| Sponsor website: | http://www.mcmaster.ca/ |
| Date applied | 26/09/2005 |
| Last edited | 11/12/2007 |
| Date ISRCTN assigned | 26/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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