Registry Platform Ovarian and Endometrial Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsoriOMEDICO AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Patients participating in PRO module: IC before first therapy cycle

Disqualifiers

newly diagnosed early-stage OC (FIGO stage I-IIa)

Low grade mOC OR

Early-stage EC (FIGO stage I-II)

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    Routine care as per site standard.

Treatment groups

1,975 Participants
are divided into 2 treatment groups
Group A: Ovarian cancer1 intervention
Group B: Endometrial cancer1 intervention

Trial outcomes

Primary outcomes

1

Course of treatment (treatment reality).

Documentation of anamnestic data and therapy sequences.

Time frame
3 years per patient

Secondary outcomes

1

Best Response.

Documentation of response rates per line of treatment.

Time frame
3 years per patient
2

Progression-free survival.

Documentation of progression-free survival per line of treatment.

Time frame
3 years per patient
3

Overall survival.

Documentation of overall survival per line of treatment.

Time frame
3 years per patient
4

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

Functional Assessment of Cancer Therapy - Ovarian (FACT-O), a 39 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Ovarian Cancer Subscale

Time frame
3 years per patient

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Multiple sites all over GermanyRecruiting Multiple LocationsGermanyGermany

Sponsors and contacts

Click on the lead sponsor to view all of their trials.