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Keyword: ACTRN12617000132347
Recruitment Status: Recruiting

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The EXCISE Study - EXcisional treatment Comparison for In Situ Endocervical adenocarinoma

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Trial Information

Trial summary

The aim of this pilot study is to compare loop electrosurgical excision procedure to cold knife cone biopsy for treatment of adenocarcinoma in situ.

Who is it for?
You may be eligible to join this study if you are a woman aged between 18 and 45 years old and have been diagnosed with adenocarcinoma in situ (AIS) with lesions amenable to single pass excision.

Study details
AIS most frequently occurs in young women (less than 45 years of age) who may wish to preserve their fertility. If this is the case, there are two treatment options available: cold knife cone (CKC) biopsy or loop electrosurgical excisional procedure (LEEP).

In Australia, CKC is regarded as the 'gold standard' treatment for AIS. However, to date most AIS studies have been limited by small patient numbers and short follow-up periods. Further evidence is required to confirm if CKC is the superior treatment type for managing AIS.

Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have their lesions removed using LEEP, whilst participants in the other group will have their lesions removed using CKC.

Following treatment, all participants will undergo the 'Test of Cure' management pathway which includes follow-up examinations at 6 and 12 months post-treatment. Assessments for early complications and patient satisfaction will occur 6 weeks post-treatment.

We are hoping to perform a pilot research study to confirm the safety and feasibility of conducting a much larger clinical trial which would be the first to compare CKC and LEEP in this way. Study findings could potentially improve patients' experiences and alter treatment guidelines since potential advantages of LEEP include the avoidance of general anaesthesia, provision of treatment in an outpatient setting, lower morbidity and reduced rates of obstetric complications.

Broad Health ConditionAdenocarcinoma in situ (AIS) of the uterine cervix

Specific Health ConditionCancer
Cervical (cervix)

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,WA,VIC

Hospital
St John of God Hospital, Subiaco - Subiaco

Hospital
The Royal Women's Hospital - Parkville

Hospital
Royal Hospital for Women - Randwick

Hospital
King Edward Memorial Hospital - Subiaco

Hospital
Westmead Hospital - Westmead

Postcode
6008 - Subiaco

Postcode
3052 - Parkville

Postcode
2031 - Randwick

Postcode
2145 - Westmead

Trial location outside Australia

Country
New Zealand

State
Auckland and Christchurch

Anticipated date of first participant enrolment19/06/2017

Anticipated date of last participant enrolment30/08/2018

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Aged between > = 18 to < = 45 years of age at time of study enrolment.
2. Documentation of AIS on cervical cytology and/or cervical biopsy test results.
3. Lesion amendable to single pass excision (serial endocervical excisions including 'top-   
    hat' will not be permitted in accordance with American Society for Colposcopy and 
    Cervical Pathology Recommendations.
4.  Proficient in English

Minimum age18 Years

Maximum age45 Years

GenderFemales

Can Healthy volunteers participate?No

Key exclusion criteria

1. High-grade cervical abnormality prior to current AIS diagnosis.
2. Previous excisional or ablative treatment (LEEP, CKC, Fisher cone biopsy, laser cone).
3. Cytology suspicious of invasion.
4. Clinical/colposcopic suspicion of invasion.
5. Presence of a concurrent gynaecological cancer.
6. Patients unable to comply with follow-up evaluations.
7. Immunosuppression.
8. Pregnancy.
9. Lesion considered unsuitable for single pass excision by treating specialist.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St John of God Hospital, Subiaco WA 6008
Primary Sponsor Address: 12 Salvado Road Subiaco WA 6008
Primary Sponsor Country: Australia

Trial websiteTBA

Trial IDACTRN12617000132347

Contact person for information and recruitmentDr
Paul Cohen
St John of God Hospital Subiaco 12 Salvado Road SUBIACO WA 6008
+61 8 9468 5188
+61 8 9381 2006
Further information iconpaul.cohen@sjog.org.au
Australia