NCT02323841|UnknownEarly Phase 1DMC
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Sponsor study identifier
interventional
30
1 country
1
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Currently conservative treatment for patients of childbearing affected by cervical cancer is reserved for women with FIGO stage IA2 - IB1 with tumor size less than 2 cm . The trachelectomy and the cone biopsy with pelvic lymphadenectomy are the choice for these patients wishing to preserve their reproductive function. In this context , recently literature show the results about the use of neo-adjuvant chemotherapy about the reduction of tumor volume and therefore the magnitude of the subsequent surgical treatment (including patients with tumors larger than 2 cm ). So it becomes crucial a prospective analysis on the possibility to include in this type of treatment patients with stage IB1 and IIA1 with tumor size greater than 2 cm ( up to 4 cm ) . The current study , in fact , would like to do a prospective evaluation on the advantages of neo-adjuvant chemotherapy in the possibility of broadening the inclusion criteria to conservative treatment in women , suffering from cervical cancer, stage IB1 and IIA1 ( with tumor volume between 2 and 4 cm) and wishing to preserve their reproductive function.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 2014
Actual (reported)April 8, 2014
Actual (reported)December 24, 2014
Actual (reported)March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
pregnancy rate
time of pregnancy. Case of miscarriage, pre-term delivery or full term delivery.
3 years
disease free survival
5 years
Overall survival
5 years
we performed conservative treatment cervix cancer patients with IB FIGO stage without pelvic involvement
we performed pelvic lymphadenectomy before neoadjuvant chemotherapy and conization as conservative treatments
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Giovanni Scambia
Rome, Italy, 00135, Italy
Russo L, Gui B, Micco M, Panico C, De Vincenzo R, Fanfani F, Scambia G, Manfredi R. The role of MRI in cervical cancer > 2 cm (FIGO stage IB2-IIA1) conservatively treated with neoadjuvant chemotherapy followed by conization: a pilot study. Radiol Med. 2021 Aug;126(8):1055-1063. doi: 10.1007/s11547-021-01377-1. Epub 2021 May 31.
de Vincenzo R, Ricci C, Fanfani F, Gui B, Gallotta V, Fagotti A, Ferrandina G, Scambia G. Neoadjuvant chemotherapy followed by conization in stage IB2-IIA1 cervical cancer larger than 2 cm: a pilot study. Fertil Steril. 2021 Jan;115(1):148-156. doi: 10.1016/j.fertnstert.2020.07.006. Epub 2020 Oct 20.
Giovanni Scambia, PhD
Catholic University of Sacred Heart
First Submitted
April 8, 2014
First Posted
December 24, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Stage-Specific Recovery Changes in the International Classification of Functioning Components Following Conservative Rehabilitation of Trigger Finger
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Study Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 24, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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