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JOURNAL ONKOLOGIE – STUDIE
SMARAGD

Registry Platform Ovarian and Endometrial Cancer

Rekrutierend

NCT-Nummer:
NCT05129969

Studienbeginn:
November 2021

Letztes Update:
08.08.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Ovarian Epithelial

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
iOMEDICO AG

Collaborator:
-

Studienleiter

Thomas Decker, Prof.Dr.
Study Chair
Ravensburg
Ingolf Juhasz-Böss, Prof.Dr.
Study Chair
Freiburg
Elmar Stickeler, Prof.Dr.
Study Chair
Aachen
Dirk Watermann, Prof.Dr.
Study Chair
Freiburg
Anja Welt, Dr.
Study Chair
Essen
Achim Wöckel, Prof.Dr.
Study Chair
Würzburg

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

Detailed Description:

SMARAGD is a national, prospective, open-label, longitudinal, non-interventional

multicenter cohort study (tumour registry platform) to describe treatment in routine

clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients

in routine care in Germany.

The registry will follow patients for up to three years with the aim to identify common

therapeutic sequences and changes in the treatment of the disease. At inclusion, data in

patient characteristics, comorbidities, tumor characteristics and previous treatments are

collected. During the course of observation data on all systemic treatments,

radiotherapies, surgeries, and outcome are documented.

Health-related quality of life (HRQoL) will be evaluated for up to three years.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Course of treatment (treatment reality). (Time Frame - 3 years per patient):
Documentation of anamnestic data and therapy sequences.



Secondary outcome:

1. Best Response. (Time Frame - 3 years per patient):
Documentation of response rates per line of treatment.

2. Progression-free survival. (Time Frame - 3 years per patient):
Documentation of progression-free survival per line of treatment.

3. Overall survival. (Time Frame - 3 years per patient):
Documentation of overall survival per line of treatment.

4. Health-related quality of life (Patient-reported outcome, PRO). (Time Frame - 3 years per patient):
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

5. Health-related quality of life (Patient-reported outcome, PRO). (Time Frame - 3 years per patient):
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

Studien-Arme

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

Geprüfte Regime

  • Physician's choice according to patient's needs.:
    Routine care as per site standard.

Quelle: ClinicalTrials.gov


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