Recruiting

Observational Study

Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Code:

NCT05284305

Conditions

Desmoid

Desmoid; Abdominal

Pregnancy Loss

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pregnancy

Study Details

Brief summary:

Desmoid tumors (DT) are rare disease of intermediate malignancy with variable and often unpredictable clinical course. There is a growing interest in defining potential risk of recurrence or progression during or after pregnancy and in identifying potential obstetrical risks and infertility rate of desmoid patients.

Aim of the study:

  • to define the impact of pregnancy on diagnosis, progression and recurrence of DT;
  • to define the risks related to DT of obstetrical risks and decisions to interrupt or avoid pregnancy after the diagnosis of DT.

Conditions

Desmoid

Desmoid; Abdominal

Pregnancy Loss

Pregnancy Complications

Study ID

NCT05284305

Start date

Mar 1, 2022

Status verified date

Jan, 2023

Completion date

May 15, 2023

Anticipated

Primary completion date

Apr 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • histologically-proven DT;
  • female patients
  • fertile age, >18 years;
  • concomitant or subsequent pregnancy (study group), or no history of pregnancy (screening group).

Exclusion Criteria:

  • suspected DT without histological diagnosis • male patients affected by DT
  • <18 years old, and non-fertile age.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with history of pregnancy

Patients with DT diagnosed during pregnancy; patients with DT with macroscopic disease in situ at the time of pregnancy (including previous partial resection, recurrent disease, primary disease followed with active surveillance); resected DT without clinical evidence of residual or recurrent disease at the onset of pregnancy.

Patients without history of pregnancy

Patients with DT without history of pregnancy

Interventions

Pregnancy

DT with a history of concomitant or subsequent pregnancy.

Primary outcome measure

  • Proportion of new disease progression during pregnancy Progression disease according to RECIST within 1 year after delivery in patients with previous stable disease. Proportion of new disease progression during pregnancy [ Time Frame: January 2000- December 2020 ]
  • Local recurrence [ Time Frame: January 2000- December 2020 ]

Central Contacts and Locations

Central contacts

Marco Fiore, MD

+390223903234marco.Fiore@istitutotumori.mi.it

Locations

Mount Sinai Hospital/Toronto University

Recruiting

Toronto, Canada, M5G 1X5

Principal Investigator:

Rebecca Gladdy

More Information

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Last update posted

Jan 27, 2023

Last verified

Jan, 2023

Keywords

  • Desmoid
  • Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano on 2023-01-27.