Registry Platform Ovarian and Endometrial Cancer

NCT05129969 | Recruiting

• 1 other identifier: IOM-110401
• Study Type: observational
• Target: 1,975
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.

Conditions

Ovarian Cancer; Endometrial Cancer; Ovary Neoplasm; Endometrial Neoplasms; Carcinoma, Ovarian; Carcinoma; Neoplasm, Ovarian

Keywords

Registry; Health service research; Epidemiology; Germany; Palliative treatment; Palliative care

Outcome Measures

Primary Outcomes (1)

• Course of treatment (treatment reality).

  Documentation of anamnestic data and therapy sequences.

  3 years per patient

Secondary Outcomes (5)

• Best Response.

  3 years per patient

• Progression-free survival.

  3 years per patient

• Overall survival.

  3 years per patient

• Health-related quality of life (Patient-reported outcome, PRO).

  3 years per patient

• Health-related quality of life (Patient-reported outcome, PRO).

  3 years per patient

Study Arms (2)

Ovarian cancer

Female patients with high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer): * with newly diagnosed FIGO stage IIb-IV OC who are starting systemic treatment, independent of the treatment intention (adjuvant/curative or palliative) or * with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting their systemic treatment for first recurrent/relapsed disease.

Other: Physician's choice according to patient's needs.

Endometrial cancer

Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.

Other: Physician's choice according to patient's needs.

Interventions

Physician's choice according to patient's needs. OTHER

Routine care as per site standard.

Endometrial cancer; Ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Ovarian or endometrial cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients with (metastatic) ovarian cancer (FIGO stage IIb-IV) or (metastatic) endometrial cancer (FIGO stage III-IV) starting systemic treatment.

You may qualify if:

• Confirmed high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):
• patients with FIGO stage IIb-IV OC who are starting systemic treatment or
• patients with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting systemic treatment for recurrent/relapsed disease.
• Locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
• Signed and dated informed consent (IC):
• Patients participating in PRO module: IC before first therapy cycle
• Patients not participating in PRO module: IC no later than six weeks after start of first therapy cycle

You may not qualify if:

• newly diagnosed early-stage OC (FIGO stage I-IIa)
• Low grade mOC OR
• Early-stage EC (FIGO stage I-II)

Sponsors & Collaborators

• iOMEDICO AG: lead

Study Sites (1)

Multiple sites all over Germany

Multiple Locations, Germany

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Carcinoma

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; Uterine Neoplasms; Uterine Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Thomas Decker, Prof.Dr.

  Ravensburg

  STUDY CHAIR

• Ingolf Juhasz-Böss, Prof.Dr.

  Freiburg

  STUDY CHAIR

• Elmar Stickeler, Prof.Dr.

  Aachen

  STUDY CHAIR

• Dirk Watermann, Prof.Dr.

  Freiburg

  STUDY CHAIR

• Anja Welt, Dr.

  Essen

  STUDY CHAIR

• Achim Wöckel, Prof.Dr.

  Würzburg

  STUDY CHAIR

Central Study Contacts

iOMEDICO AG

CONTACT

+49 761 15242-0; info@iomedico.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: November 25, 2021
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)