Evaluation of IL-6 and IL-8 as prognostic markers after local ablation therapy of breast or abdominal lesions (ESTIMATE)
Organizational Data
- DRKS-ID:
- DRKS00010587
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2019-05-23
- Last update in DRKS:
- 2024-01-02
- Registration type:
- Retrospective
Acronym/abbreviation of the study
ESTIMATE
URL of the study
Brief summary in lay language
No Entry
Brief summary in scientific language
Pretherapeutic serum concentrations of IL-6 and IL-8 have a prognostic value for overall survival of patients receiving local ablation therapy for breast or abdominal tumors.
Health condition or problem studied
- ICD10:
- C50 - Malignant neoplasm of breast
- ICD10:
- C22 - Malignant neoplasm of liver and intrahepatic bile ducts
- ICD10:
- C20 - Malignant neoplasm of rectum
- Free text:
- Indication for local ablative therapy of malignancies
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Parameters such as IL-6 and IL-8 following locally ablative therapy as the radioembolization prognostic value for overall survival have not been studied. Evaluating the valence of IL-6 and IL-8 should be the goal of the study. Patients with lung tumors or liver tumors undergoing image-guided local therapy (HDR brachytherapy in the afterloading procedure (HDR), radiofrequency ablation (RFA) or microwave ablation (MWA)) will be taken for pre-therapeutic blood sampling. Parameters like IL-6 and IL-8 are determined at the end of the recruitment period.
Endpoints
- Primary outcome:
- Evaluation of pre-treatment IL-6 and IL-8 concentration as prognostic marker for overall survival after image-guided therapy lokalablativer (HDR, MWA, RFA) intrathoracic or intra-abdominal malignancies.
- Secondary outcome:
- /
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Klinik für Radiologie und Nuklearmedizin Magdeburg
- University medical center Klinik für Radiologie und Nuklearmedizin Magdeburg
- University medical center Klinik und Poliklinik für Radiologie München
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2017-07-20
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-12-27
- Target Sample Size:
- 800
- Final Sample Size:
- 560
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- • primary or secondary metastsis of lungs-cancer and HCC. • male or female, > 18 years • Indication of HDR brachytherapy, microwave ablation or radiofrequency ablation in one or more sessions • Patient confirms all study procedures (taking blood sample like routine diagnostics) • Signed informed consent
Exclusion Criteria
• contraindication for local ablative therapies Life expectancy <3 months
Addresses
Primary Sponsor
- Address:
- Klinikum der Universität München, Campus GroßhadernMarchioninistraße 1581377 MünchenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinikum der Universität München, Klinik und Poliklinik für Radiologie, LMUDr. med. Sergio Roman GrosuMarchioninistr. 1581377 MünchenGermany
- Telephone:
- 089-440072750
- Fax:
- (089) 4400-76648
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/de/index.html
Contact for Public Queries
- Address:
- Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus GroßhadernChristel BesselerMarchioninistr. 1581377 MünchenGermany
- Telephone:
- (089) 4400-73647
- Fax:
- (089) 4400-76648
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://intranet.klinikum.uni-muenchen.de/de/index.html
Principal Investigator
- Address:
- Klinikum der Universität München, Klinik und Poliklinik für Radiologie, LMUDr. med. Sergio Roman GrosuMarchioninistr. 1581377 MünchenGermany
- Telephone:
- 089-440072750
- Fax:
- (089) 4400-76648
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/de/index.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinikum der Universität München, Campus GroßhadernMarchioninistraße 1581377 MünchenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Med. Fakultät der LMUPettenkoferstraße 880336 MünchenGermany
- Telephone:
- +49-89-440055191
- Fax:
- +49-89-440055192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-04-20
- Ethics committee number:
- 17-346
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-06-20
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- LMU-RAD00006 - internes Register
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:
- EJNMMI Res . 2021 Jun 2;11(1):51. doi: 10.1186/s13550-021-00791-w.
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Öcal O, Kupčinskas J, Morkunas E, Amthauer H, Schütte K, Malfertheiner P, Klümpen HJ, Sengel C, Benckert J, Seidensticker R, Sangro B, Wildgruber M, Pech M, Bartenstein P, Ricke J, Seidensticker M. Prognostic value of baseline interleukin 6 levels in liver decompensation and survival in HCC patients undergoing radioembolization. EJNMMI Res. 2021 Jun 2;11(1):51. doi: 10.1186/s13550-021-00791-w. PMID: 34080071; PMCID: PMC8172845.
- Date of first publication of study results:
- 2021-06-02
- DRKS entry published for the first time with results:
- 2024-01-02
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- In advanced HCC patients receiving 90Y radioembolization combined with sorafenib, baseline IL6 values proved to be prognostic, confirming previous findings in patients undergoing 90Yradioembolization. IL6 might be useful for patient selection or stratification in future trials.