Registry Platform Ovarian and Endometrial Cancer

NCT05129969RecruitingOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

iOMEDICO AG

Enrollment

1975

Start Date

2021-11-25

Completion Date

2030-12-01

Study Type

OBSERVATIONAL

Official Title

SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes

Interventions

Physician's choice according to patient's needs.

Conditions

Ovarian CancerEndometrial CancerOvary NeoplasmEndometrial NeoplasmsCarcinomaOvarianCarcinomaNeoplasmOvarian

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* 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

Exclusion Criteria:

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

Outcome Measures

Primary Outcomes

Course of treatment (treatment reality).

Documentation of anamnestic data and therapy sequences.

Time frame: 3 years per patient

Secondary Outcomes

Best Response.

Documentation of response rates per line of treatment.

Time frame: 3 years per patient

Progression-free survival.

Documentation of progression-free survival per line of treatment.

Time frame: 3 years per patient

Overall survival.

Documentation of overall survival per line of treatment.

Time frame: 3 years per patient

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

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

Functional Assessment of Cancer Therapy - Endometrial (FACT-En), a 43 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Endometrial Cancer Subscale

Time frame: 3 years per patient

Locations

Multiple sites all over Germany, Multiple Locations, Germany

Registry Platform Ovarian and Endometrial Cancer