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Predictors of Therapeutic Response in Ovarian Carcinoma NCT01391351 - Eligibility Criteria

- 23-06-19 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Search for Predictors of Therapeutic Response in Ovarian Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01391351 In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).

PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING) Roche H0650g Breast Cancer - PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING)

- 15-03-21 - 1 Formulier, 3 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Chemotherapy, Therapeutic regimen, ADJUVANT THERAPY
Study part: Prior treatment for breast cancer (Adjuvant setting). A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Study Medication 5 Days On, 2 Days Off for 3 Weeks Regimen

- 05-07-19 - 1 Formulier, 5 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Body Weight, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Study Medication Daily X5 Days Regimen

- 05-07-19 - 1 Formulier, 3 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Body Weight, Body Surface Area, Topotecan, Chemotherapy Regimen
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Study Medication 5 Days On, 2 Days Off for 3 Weeks Regimen

- 05-07-19 - 1 Formulier, 6 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Body Weight, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Dose Reduced
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Oral Topotecan Daily X5 Days Regimen

- 05-07-19 - 1 Formulier, 3 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Body Weight, Body Surface Area, Topotecan, Chemotherapy Regimen
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Visit 12 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 12

- 17-02-16 - 1 Formulier, 5 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Visit 12: Fourth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 14 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 14

- 17-02-16 - 1 Formulier, 5 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Visit 14: Sixth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 13 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 13

- 17-02-16 - 1 Formulier, 5 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Visit 13: Fifth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 11 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 11

- 17-02-16 - 1 Formulier, 5 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Visit 11: Third cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 10 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 10

- 16-02-16 - 1 Formulier, 5 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Visit 10: Second cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 9 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 9

- 16-02-16 - 1 Formulier, 5 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Visit 9: First cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

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