Genetic alterations during treatment of oligometastatic colorectal cancer (GATTACA)
Organizational Data
- DRKS-ID:
- DRKS00006294
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2017-01-12
- Last update in DRKS:
- 2023-02-16
- Registration type:
- Retrospective
Acronym/abbreviation of the study
GATTACA
URL of the study
No Entry
Brief summary in lay language
Aim of this pilot study is to assess the influence of local tumor irradication on the evolution of genetic alterations of circulating tumor DNA in metastatic colorectal carcinoma undergoing systemic chemotherapy plus targeted therapy.
Brief summary in scientific language
Assesment of the Influences on the evolution of genetic alterations of circulating tumor DNA in patients with metastasized CRC undergoing chemotherapie and local tumor irradication.
Health condition or problem studied
- ICD10:
- C20 - Malignant neoplasm of rectum
- ICD10:
- C19 - Malignant neoplasm of rectosigmoid junction
- ICD10:
- C18 - Malignant neoplasm of colon
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients treated in this study receive a local Therapy (Thermal ablation, Brachytherapy, Mikrowaveablation, stereotactical radiation, surgical resection) after there has been a progress while undergoing Chemotherapy. The study will only accompany the intended Treatment, but not influence the chosen methods. During the study additional blood samples will be taken during routine blood draws to examinate whether changes in free floating DNA will occur after local Therapy.
Endpoints
- Primary outcome:
- There is a proportionality between the fall of the free-circulating tumor DNA 8 weeks after therapy and 16-72 week interval and the progression free survival and / or overall survival. (Check of the degree of response)
- Secondary outcome:
- Is tumor recurrence (Progression free survival) associated with a different profile of genetic alterations?
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 complete, study continuing
- Reason if recruiting stopped or withdrawn: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 Leipzig
- 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:
- 2016-03-02
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 90
- Final Sample Size:
- 87
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 1. histologically proven oligometastatic colorectal cancer (Oligometastatic disease status defined as involving up to 3 organ systems; up to 3 metastases per organ system) 2. Any treatment line irrespective of previous chemotherapy lines 3.Patient treatment recommendation confirmed by an institutional multidisciplinary tumor board (MDT) 4.Metastases amenable to complete ablation/resection using different techniques (radiofrequency ablation, thermoablation, photon beam radiation, surgery, including minimal invasive resections) 5.Age >18 Jahre 6.Life expectancy > 12 months 7. signed and dated consent form
Exclusion Criteria
1. Patients with metastases involving more than 3 organ systems (e.g. liver, lung, bone and retroperitoneal compartment) 2. Patients with peritoneal or pleural metastases 3. Patient having undergone Whipple Operation 4. Second carcinoma, except carcinoma in situ of the cervix or basal cell carcinoma. 5. Pregnancy
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:
- Klinik für Radiologie und NuklearmedizinUniversität MagdeburgProf. Jens RickeLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- +391-6713030
- Fax:
- +391-6713029
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-magdeburg.de/fme/zrad/kdr/
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:
- Klinik für Radiologie und NuklearmedizinUniversität MagdeburgProf. Jens RickeLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- +391-6713030
- Fax:
- +391-6713029
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-magdeburg.de/fme/zrad/kdr/
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:
- Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.Leipziger Str. 44 Haus 2839120 MagdeburgGermany
- Telephone:
- +49-391-6714314
- Fax:
- +49-391-67290185
- 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:
- 2014-06-30
- Ethics committee number:
- 95/14
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-07-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- LMU-RAD00001 - Klinik und Poliklinik für Radiologie
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:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry