Desmoid Tumor and Pregnancy: Effect of Pregnancy on Disease Control and Effect of Diagnosis on Pregnancy History.

NCT05284305 | Unknown

• 1 other identifier: INT82/21
• Study Type: observational
• Target: 400
• Locations: 4 countries
• Sites: 7

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

Keywords

Desmoid; Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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

  Progression disease according to RECIST within 1 year after delivery in patients with previous stable disease.

  January 2000- December 2020

• Local recurrence

  Local recurrence detected during pregnancy or within 1 year after delivery

  January 2000- December 2020

Secondary Outcomes (5)

• Time to progression

  January 2000- December 2020

• Spontaneous regression

  January 2000- December 2020

• Proportion of patients shifting from active surveillance/no treatment to active treatment

  January 2000- December 2020

• Rate of spontaneous and induced abortion

  January 2000- December 2020

• Rate of obstetric and delivery complications

  January 2000- December 2020

Study Arms (2)

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.

Other: Pregnancy

Patients without history of pregnancy

Patients with DT without history of pregnancy

Interventions

Pregnancy OTHER

DT with a history of concomitant or subsequent pregnancy.

Patients with history of pregnancy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients above the age of 18 affected by DT with a history of concomitant or subsequent pregnancy prospectively followed at the partecipating institutions between January 2000 and December 2020. Patients will be divided in 3 groups: a) DT diagnosed during pregnancy; b) DT with macroscopic disease in situ at the time of pregnancy (including previous partial resection, recurrent disease, primary disease followed with active surveillance); c) resected DT without clinical evidence of residual or recurrent disease at the onset of pregnancy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• University of Padova: collaborator
• Institut Curie: collaborator
• Dana-Farber/Brigham and Women's Cancer Center: collaborator
• Mount Sinai Hospital, Canada: collaborator
• Desmoid Foundation Italia: collaborator
• Istituto Oncologico Veneto IRCCS: collaborator

Study Sites (7)

Brigham and Women Hospital / Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

COMPLETED

Mount Sinai Hospital/Toronto University

Toronto, M5G 1X5, Canada

RECRUITING

Institut Curie

Paris, France

COMPLETED

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

COMPLETED

Desmoid Foundation Italy

Milan, Italy

RECRUITING

Istituto Oncologico Veneto IRCSS

Padua, Italy

WITHDRAWN

University of Padova

Padua, Italy

WITHDRAWN

MeSH Terms

Conditions

Desmoid Tumors; Panniculitis, Peritoneal; Pregnancy Complications

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Peritoneal Diseases; Digestive System Diseases; Panniculitis; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Marco Fiore, MD

  Fondazione IRCSS Istituto Nazionale Tumori

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Fiore, MD

CONTACT

+390223903234; marco.Fiore@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: March 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 15, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); CA (1); US (1); FR (1)