Prognostic Value of Conization and Negative HPV After Conization in AIS and Early Stage Cervical Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-85
SponsorRambam Health Care Campus
About this trial
In women with cervical cancer -Squamous cell carcinoma, Adeno carcinoma,
Adeno-squamous carcinoma or AIS we want to examine prospectively:
1. Examine if negative HR-HPV after conization to the HR-HPV the women had before conization has a high prognostic value for no residual tumor in the final pathology. 2. To examine if conization in women with cervical tumor up to Stage I B 2 (FIGO 2018) is corelated with better prognosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Women with cervical cancer -Squamous cell carcinoma, Adeno carcinoma, Adeno-squamous carcinoma or AIS
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 4 trial groupsGroup A: Post Conization HR HPV positive
Group B: Post Conization HR HPV negative
Group C: No Conization HR HPV positive
Group D: No Conization HR HPV negative
Trial outcomes
Primary outcomes
1
Final Pathology
Residual disease in final pathology
Time frame
1 yearSecondary outcomes
1
Disease recurrence
number of months until Disease recurrence
Time frame
5 year2
Mortality
mortality rate during the study between the groups
Time frame
5 year3
complications
major complications
Time frame
5 yearSponsors and contacts
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Source ClinicalTrials.gov