Ovarian Cancer Clinical Trial
— SMARAGDOfficial title:
SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
NCT number | NCT05129969 |
Other study ID # | IOM-110401 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 25, 2021 |
Est. completion date | December 2027 |
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.
Status | Recruiting |
Enrollment | 1300 |
Est. completion date | December 2027 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Germany | Multiple sites all over Germany | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
iOMEDICO AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Course of treatment (treatment reality). | Documentation of anamnestic data and therapy sequences. | 3 years per patient | |
Secondary | Best Response. | Documentation of response rates per line of treatment. | 3 years per patient | |
Secondary | Progression-free survival. | Documentation of progression-free survival per line of treatment. | 3 years per patient | |
Secondary | Overall survival. | Documentation of overall survival per line of treatment. | 3 years per patient | |
Secondary | 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 | 3 years per patient | |
Secondary | 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 | 3 years per patient |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |