International Registration of Isolated STIC: to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis

NCT06393543 | Not Yet Recruiting

• 1 other identifier: 2024-17277
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

To prospectively assess the incidence of peritoneal carcinomatosis for women with isolated STIC (serous tubal intraepithelial carcinoma). Moreover, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of peritoneal carcinomatosis and to report the findings of additional diagnostics.

Conditions

BRCA Mutation; Serous Tubal Intraepithelial Carcinoma; Ovarian Carcinoma; Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• The risk for peritoneal carcinomatosis in women with isolated STIC

  10 years

Secondary Outcomes (3)

• Risk factors

  5-10 years

• Histopathological characteristics

  5-10 years

• Additional diagnostics

  3 months

Study Arms (2)

Retrospective cohort

Women with isolated STIC diagnosed between 2015 and the start of the study.

Other: No intervention, only registration

Prospective cohort

Women with a newly diagnosed isolated STIC

Other: No intervention, only registration

Interventions

No intervention, only registration OTHER

No intervention, only registration

Prospective cohort; Retrospective cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

For the retrospective cohort: All women with STIC diagnosed between 2015 and start of the prospective study are identified. Data up until that time-point will be collected. At the end of the data collection follow-up will be updated on the women in the retrospective cohort. For the prospective cohort: All consecutive women with isolated STIC from participating centres are informed on the study and requested to participate.

You may qualify if:

• Women
• Bilateral salpingectomy (with or without oophorectomy)
• A serous tubal intraepithelial carcinoma at histopathological review

You may not qualify if:

• Invasive cancer at initial surgery or pathological examination (either macroscopic and/or microscopic)

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Miranda Steenbeek, MD PhD

CONTACT

0031615909405; miranda.steenbeek@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share