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Imiquimod Treatment of Residual or Recurrent CIN Lesions: a Study Protocol (TopIC-2)

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ClinicalTrials.gov Identifier: NCT02669459
Recruitment Status : Unknown
Verified February 2018 by A.J.M. van de Sande, Erasmus Medical Center.
Recruitment status was:  Recruiting
First Posted : February 1, 2016
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
Maastricht University Medical Center
Meander Medisch Centrum
Albert Schweitzer Hospital
Sint Franciscus Gasthuis
Catharina Ziekenhuis Eindhoven
Information provided by (Responsible Party):
A.J.M. van de Sande, Erasmus Medical Center

Brief Summary:
The purpose of this study is to investigate if imiquimod can be used as a non-invasive option in the treatment of residual/recurrent CIN lesions.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Drug: Imiquimod Procedure: LLETZ Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Single Blinded Trial to Evaluate the Efficacy of Imiquimod in Women With Residual/Recurrent Cervical Intraepithelial Neoplasia (CIN) After Previous Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Active Comparator: LLETZ
LLETZ (Large Loop excision of the transformation zone) treatment conform current guidelines, which is also the current gold standard in the Netherlands
Procedure: LLETZ
surgical treatment for CIN, current gold standard
Other Name: Large Loop Excision of the transformation zone

Imiquimod 5% cream
intervention group
Drug: Imiquimod
12,5 mg imiquimod three times per week during 16 weeks
Other Name: aldara




Primary Outcome Measures :
  1. Reduction to normal cytology [ Time Frame: 6 months after treatment ]

Secondary Outcome Measures :
  1. Reduction to no dysplasia [ Time Frame: 10 weeks after the treatment ]
    only Imiquimod group

  2. presence or absence of HPV DNA in CIN lesions [ Time Frame: presence in biopsy before start treatment, cervical smear 6 months after treatment ]
    Biopsy which is take prior to treatment for inclusion in the study

  3. tolerability to the treatment/side effects [ Time Frame: At 6 months, worst grade observed. ]
    Side effects (headache, fever, fatigue, myalgia, vaginal discharge, vaginal bleeding, vaginal pain/itch, vaginal swelling, other) noted in CTCAE grade (no side effects to grade 4)

  4. tolerability to the treatment/side effects [ Time Frame: At 6 months, worst grade observed. ]
    Side effects (headache, fever, fatigue, myalgia, vaginal discharge, vaginal bleeding, vaginal pain/itch, vaginal swelling, other) noted in VAS score (0-10)

  5. quality of life [ Time Frame: at inclusion for study, 6 and 12 months after start treatment ]
    QOL measured with RAND-36 scoring

  6. quality of life [ Time Frame: at inclusion for study, 6 and 12 months after start treatment ]
    QOL measured with QLQ-C30 scoring

  7. quality of life [ Time Frame: at inclusion for study, 6 and 12 months after start treatment ]
    QOL measured with QLQ-CX24 scoring

  8. durability of the clinical response [ Time Frame: PAP 1 at 12 and 24 months after the start treatment. ]
    Cervical smear taken at 12 and 24 months after start treatment in both groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven CIN 2 or CIN 3, without invasion after previous surgical treatment at least 6 months before diagnosis.
  • Histologically proven recurrent CIN 1 after previous surgical treatment at least 6 months before diagnosis. Persistent CIN 1 is defined as CIN 1 at least persistent for 6 months and proven with histology.
  • The patient is willing to use a medically acceptable method of contraception throughout the study
  • Women older than 18 years of age.

Exclusion Criteria:

  • Pregnancy or lactation
  • (Micro-)invasive carcinoma
  • Past history of cervical cancer
  • Hypersensitivity of any components of the formulation
  • History of psoriasis or other inflammatory dermatosis of the vulva
  • Immunodeficiency or treatment with immunosuppressive medication
  • Insufficient understanding of the Dutch or English language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669459


Contacts
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Contact: Meike van de Sande, MD 0031-6-22196507 a.vandesande@erasmusmc.nl

Locations
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Netherlands
Erasmus Medical center Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Contact: Meike van de Sande, MD    0031-6-22196507    a.vandesande@erasmusmc.nl   
Contact: Heleen van Beekhuizen, MD    0031-6-81824400    h.vanbeekhuizen@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center
Maastricht University Medical Center
Meander Medisch Centrum
Albert Schweitzer Hospital
Sint Franciscus Gasthuis
Catharina Ziekenhuis Eindhoven
Investigators
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Principal Investigator: Heleen van beekhuizen, MD Erasmus MC
Publications of Results:
de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin HR, Vallejos CS, de Ruiz PA, Lima MA, Guimera N, Clavero O, Alejo M, Llombart-Bosch A, Cheng-Yang C, Tatti SA, Kasamatsu E, Iljazovic E, Odida M, Prado R, Seoud M, Grce M, Usubutun A, Jain A, Suarez GA, Lombardi LE, Banjo A, Menéndez C, Domingo EJ, Velasco J, Nessa A, Chichareon SC, Qiao YL, Lerma E, Garland SM, Sasagawa T, Ferrera A, Hammouda D, Mariani L, Pelayo A, Steiner I, Oliva E, Meijer CJ, Al-Jassar WF, Cruz E, Wright TC, Puras A, Llave CL, Tzardi M, Agorastos T, Garcia-Barriola V, Clavel C, Ordi J, Andújar M, Castellsagué X, Sánchez GI, Nowakowski AM, Bornstein J, Muñoz N, Bosch FX; Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010 Nov;11(11):1048-56. doi: 10.1016/S1470-2045(10)70230-8. Epub 2010 Oct 15.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: A.J.M. van de Sande, A. van de Sande, MD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02669459    
Other Study ID Numbers: NL 53792.078.15
2015-002308-10 ( EudraCT Number )
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by A.J.M. van de Sande, Erasmus Medical Center:
Cervical Intraepithelial Neoplasia
Imiquimod
Human papillomavirus
quality of life
biological markers
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers