CONSERVATIVE MANAGEMENT OF ENDOMETRIAL CANCER AND ATYPICAL HYPERPLASIA - ND

Conditions

MedDRA version: 9.1 Level: LLT Classification code 10007063

Francesca Falcone, Nicola Normanno, Simona Losito, Giosuè Scognamiglio, Riziero Esposito Abate et al. (8 authors)

2019-11-013 citations

10.1136/ijgc-2019-esgo.1162

Application of the Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE) to patients conservatively treated: Outcomes from an institutional series.

Falcone F, Normanno N, Losito NS, Scognamiglio G, Esposito Abate R, Chicchinelli N, Casella G, Laurelli G, Scaffa C, Greggi S.

2019-07-1335 citations

10.1016/j.ejogrb.2019.07.013

Interventions

Trade Name: MIRENA*DISP.INTRAUT.20MCG/24H Pharmaceutical Form: INN or Proposed INN: Plastic IUD with progestogen Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 52

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? age ≤ 40 years ? BMI ≤ 36 ? P.S. WHO scale 0-1 ? diagnosis of well differentiated stage IA (intramucous) EEC or EAI ? ER/PR positive ? normal serum levels of CA125 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? multifocal endometrial cancer ? concomitant cancers except for properly treated cutaneous basocellular carcinoma and in situ cervical carcinoma. ? HPNCC-Lynch II syndrome ? controindications for LNG-IUD insertion ? AIDS ? acute and chronic liver diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of efficacy and safety profile of combined conservative treatment in women aged ≤ 40 years with well differentiated stage IA (intramucous) EEC or EAI using operative HSC and LNG-IUD;Secondary Objective: spontaneous pregnancy rate - assisted reproduction technology (ART) pregnancy rate;Primary end point(s): recurrence-free rate, morbidity	—

Countries

Italy

Outcome results

None listed