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„Caroline meets HANNA – Holistic Analysis of LoNgterm-survival with OvariaN CAncer” Expression VI

Organizational Data

DRKS-ID:
DRKS00011339
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2016-12-02
Last update in DRKS:
2024-02-13
Registration type:
Retrospective

Acronym/abbreviation of the study

Expression VI

URL of the study

http://carolinmeetshanna.com

Brief summary in lay language

Every year a high number of women fall ill on ovarian cancer. Only abou 41% survive a timeframe of 5 years after their intial diagnosis. Even less women survive a timeframe of 8 years with or withour recurrence. In this study facors which favour longterm survival with ovarian cancer shall be identified.

Brief summary in scientific language

Identification of factors for longterm survival with ovarian cancer. We understand longerterm survivors as patients who survived a time frame of at least eight years after their initial diagnosis (with or without recurrence). Factors to be analysed are: - basic data (age at diagnosis, co-medication, comorbidities, tumor stage, treatment) - side effects, follow on treatment, aftercare, participation in studies - social factors - psycologic factors (resilience, coping) - quality of life - nutrition, religion, sports, sleep

Health condition or problem studied

ICD10:
C56 - Malignant neoplasm of ovary
ICD10:
C48 - Malignant neoplasm of retroperitoneum and peritoneum
ICD10:
C57 - Malignant neoplasm of other and unspecified female genital organs
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Questionnaire with 68 questions regarding - basic data (age at diagnosis, co-medication, comorbidities, tumor stage, treatment) - side effects, follow on treatment, aftercare, participation in studies - social factors - psycologic factors (resilience, coping) - quality of life - nutrition, religion, sports, sleep

Endpoints

Primary outcome:
Identification of factors for long term survival
Secondary outcome:
na

Study Design

Purpose:
Prognosis
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
  • Belgium
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Lebanon
  • Poland
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Switzerland
  • Turkey
  • Ukraine
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Klinikum Wolfsburg Wolfsburg
  • Other Praxis Busch Mühlhausen
  • Medical center Klinikum Wolfsburg Wolfsburg
  • Other Praxis Busch Mühlhausen
  • Medical center Essen Mitte Essen
  • Medical center Vivantes Humboldt Klinikum Berlin
  • Medical center Katharinen Hospital Unna
  • Other Praxis Schilling Berlin
  • University medical center Charité Universitätsmedizin Berlin Berlin
  • Medical center Frauenklinik UMG Göttingen
  • Medical center Klinikum Bayreuth GmbH Bayreuth
  • Medical center Klinikum Chemnitz Chemnitz
  • Medical center St. Elisabeth-Krankenhaus Köln-Hohenlind Köln
  • Medical center Klinikum Speyer Speyer
  • Other Praxis Ruhmland Berlin
  • Medical center Klinikum Fürth Fürth
  • Medical center Diakoniekrankenhaus Bremen
  • Medical center Lahn Dill Kliniken Wetzlar Wetzlar
  • University medical center Uni Dresden Dresden
  • Medical center St. Marien (Siegen) Siegen
  • Medical center Klinikum Offenburg-Gengenbach Offenburg-Gengenbach
  • Doctor's practice Praxis Oskay Berlin
  • University medical center LMU München
  • Medical center Helios Klinikum Schwerin Schwerin
  • University medical center Universitätsfrauenklinik Köln
  • Medical center Helios Wiesbaden Wiesbaden
  • Medical center Vivantes Klinikum Neukölln Berlin
  • Medical center St Johannes Hospital Dortmund Dortmund
  • University medical center Universitätsmedizin Greifswald Greifswald
  • Medical center Krankenhaus St. Elisabeth und St. Barbara Halle Saale
  • Medical center Regio Klinik Pinneberg Pinneberg
  • Medical center Sozialstiftung Bamberg Bamberg
  • University medical center Universtitäsklinikum Tübingen Tübingen
  • Medical center Diakonissenkrankenhaus Mannheim Mannheim
  • Medical center Krankenhaus Waldfriede e.V. Berlin
  • Medical center Vivantes Auguste-Viktoria-Klinikum Berlin
  • Medical center Städtisches Klinikum Solingen Solingen
  • Medical center Regio Kliniken Pinneberg Pinneberg
  • Medical center Main-Kinzig-Kliniken Gelnhausen
  • Medical center Böblingen

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2016-11-15
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
300
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
Female
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- initial diagnosis at least five years ago - ovarian, peritoneal or fallopian tube cancer

Exclusion Criteria

- Other gynaecological tumours

Addresses

Primary Sponsor

NOGGO e.V.
Schwedenstr. 9
13359 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Charité Universitätsmedizin Berlin
Dr. Hannah Woopen
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
0049 30 664 458
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Charité Universitätsmedizin Berlin
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
0049 30 664 458
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Charité Universitätsmedizin Berlin
Dr. Hannah Woopen
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
0049 30 664 458
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

AstraZeneca
22880 Wedel
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Private sponsorship (foundations, study societies, etc.)

Stiftung Eierstockkrebs
13353 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://stiftung-eierstockkrebs.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Charité – Universitätsmedizin Berlin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
(+49)30-450517222
Fax:
(+49)30-450517952
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2016-07-25
Ethics committee number:
EA2/139/16
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-08-12

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
Pubmed Abstract
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Woopen H, Keller M, Zocholl D, et al. Side Effects from Cancer Therapies and Perspective of 1044 Long-Term Ovarian Cancer Survivors-Results of Expression VI-Carolin Meets HANNA-Holistic Analysis of Long-Term Survival with Ovarian Cancer: The International NOGGO, ENGOT, and GCIG Survey. Cancers (Basel). 2023;15(22):5428. Published 2023 Nov 15. doi:10.3390/cancers15225428
Date of first publication of study results:
2023-11-15
DRKS entry published for the first time with results:
2024-02-13

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry