Trial document
DRKS00018788
Trial Description
Title
A monocenter registry study to document clinical, biological and quality of life parameters in patients with gastrointestinal tumors
Trial Acronym
GASTRY
URL of the Trial
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Brief Summary in Lay Language
Documentation of patient data of patients with gastrointestinal tumors or unknown primary including measurement of life quality.
Brief Summary in Scientific Language
A monocenter registry for documenting clinical, biological and quality of life parameters in patients with gastrointestinal tumors.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
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Organizational Data
- DRKS00018788
- 2020/01/14
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- yes
- Approved
- F-2019-066, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
Secondary IDs
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Health Condition or Problem studied
- Gastrointestinal tumors
- CUP-SYNDROM
- C15-C26 - Malignant neoplasms of digestive organs
- C80 - Malignant neoplasm, without specification of site
Interventions/Observational Groups
- Documentation of clinical data including molecular diagnostic results and quality of life in patients with gastrointestinal tumors or unknown primary.
Characteristics
- Non-interventional
- Other
- Other
- Open (masking not used)
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- Other
- Other
- Other
- N/A
- N/A
Primary Outcome
Comparison of Overall Survival between patients who received a molecular-stratified therapy after first tumor progression at latest and patients who did not.
Secondary Outcome
- Comparison of PFS with molecular-stratified therapy and preceding therapy (PFS-Ratio)
- Evaluation of efficacy of therapies with pre-defined parameters
- Evaluation of Tumor board decisions
- Development of a molecular map based on NGS analyses, sub-typing of molecular signalling pathways
- Correlation between mutational status and clinical parameters resp. quality of life
- Identification of prognostic and predictive factors
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2020/01/01
- 100
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
• Patients with advanced GI Tumor or CUP Syndrome and indication of systemic treatment
• Molecular examination indicated
• Age ≥18 Jahre
• Written informed consent
Exclusion Criteria
• Severe neurologic or psychiatric disorders which interfere with the patient's ability to provide informed consent
Addresses
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start of 1:1-Block address primary-sponsor
- SLK-Kliniken Heilbronn GmbH
- Am Gesundbrunnen 20-26
- 74078 Heilbronn
- Germany
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end of 1:1-Block address contact primary-sponsor -
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- SLK-Kliniken Heilbronn GmbH
- Ms. Dr. rer.nat. Dilyana Vladimirova
- Am Gesundbrunnen 20-26
- 74078 Heilbronn
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49-7131-49-28212
- +49-7131-49-47-28700
- dilyana.vladimirova at slk-kliniken.de
- http://www.slk-kliniken.de
end of 1:1-Block address contact scientific-contact -
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- SLK-Kliniken Heilbronn GmbH
- Mr. Josef Huber
- Am Gesundbrunnen 20-26
- 74078 Heilbronn
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49-7131-49-28700
- +49-7131-49-47-28700
- josef.huber at slk-kliniken.de
- http://www.slk-kliniken.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- SLK-Kliniken Heilbronn GmbH
- Am Gesundbrunnen 20-26
- 74078 Heilbronn
- Germany
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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