Cancer Clinical Trial
— TQ-BIRDOfficial title:
Tumor Control, Treatment Toxicity, Quality of Life and Bio-Imaging Repository Databank (TQ-BIRD) for Cancer Patients-A Master Protocol for Imaging and Blood Biomarker Group
NCT number | NCT05061342 |
Other study ID # | GCOG0001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 27, 2019 |
Est. completion date | October 14, 2024 |
Our central hypothesis is that patient response to treatment, evaluated by full spectrum of outcome measures including tumor control, survival, toxicity, and quality of life (QoL), will correlate with biomarker expressions, which can be tested in the blood, other body fluid, imaging as well as tumor tissue (if available).
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | October 14, 2024 |
Est. primary completion date | June 14, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Cancer Patients - 18 years of age and older. - Scheduled to receive any kind of therapy in our center. - Performance status of ECOG 0, 1, 2, or 3. - Able to understand QoL questionnaire. Normal (non cancer) controls - 18 years of age and older healthy volunteers. - Without a history of cancer except for cured skin cancer, without any active cancer. - ECOG Performance status 0, 1, 2, or 3. Exclusion Criteria: Participants who have supposedly limited ability to complete the survey questionnaires of the present study will be excluded. |
Country | Name | City | State |
---|---|---|---|
China | UHongKongShenzhen | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Fengming Kong | The University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor control, treatment toxicity, quality of life | Changes of treatment-related adverse events as assessed by CTCAE v5.0, and changes of quality of life as assessed by PROMIS-29 Profile v2.1. from baseline, during and after treatment until 2 years after treatment. Tumor response, tumor control, progression-free survival (PFS), cause-specific survival (CSS) and overall survival (OS) evaluated until patients' death or lost to follow-up. Changes of treatment-related adverse events as assessed by CTCAE v5.0, and changes of quality of life as assessed by PROMIS-29 Profile v2.1. from baseline, during and after treatment until 2 years after treatment. Tumor response, tumor control, progression-free survival (PFS), cause-specific survival (CSS) and overall survival (OS) evaluated until patients' death or lost to follow-up. |
Changes of treatment toxicity and quality of life will be evaluated before, during and after treatment until 2 years after treatment. Treatment efficacy including tumor control will be evaluated until patients' death or lost to follow-up. | |
Secondary | Bio-Imaging-Repository-Databank (BIRD) | Prospectively collect and store body fluids samples from cancer patients treated with various anticancer treatments, including palliative care to establish a bio-Imaging-repository-databank covering an extensive repository and prospective clinically relevant data. | Blood, feces, urine and saliva will be collected, whenever possible before, during and after treatment for at least four times (baseline, middle, at the end and the first follow-up around 1-3 months after treatment. |
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