Tumor Control, Treatment Toxicity, Quality of Life and Bio-Imaging Repository Databank (TQ-BIRD) for Cancer Patients
TQ-BIRD
1 other identifier
observational
5,000
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2019
CompletedFirst Submitted
Initial submission to the registry
May 21, 2021
CompletedFirst Posted
Study publicly available on registry
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
January 27, 2026
January 1, 2026
10.5 years
May 21, 2021
January 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Bio-Imaging-Repository-Databank (BIRD)
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.
Study Arms (2)
Cancer Patients
Those with cancer.
Normal (non cancer) controls
Those without cancer.
Interventions
Any anticancer or palliative care
Eligibility Criteria
All adult patients received any form of treatment (radiotherapy, surgery, systemic therapy, palliative and alternative cares) in the cancer center will be invited to participate. Patients with clinical diagnosis of tumor or related diseases such as hepatitis, gastritis, and Myasthenia Gravis will also be eligible, particularly should the patient be taken to OR for such treatments or being monitored for the risk of cancer developments. Healthy volunteers of various ages will also be enrolled from the general public for controls and setting up normal ranges of the interested biomarkers.
You may qualify if:
- Cancer Patients
- 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
- 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.
You may not qualify if:
- Participants who have supposedly limited ability to complete the survey questionnaires of the present study will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Henan Medical Universitycollaborator
- Fengming Konglead
- Queen Mary Hospital, Hong Kongcollaborator
- Taizhou Hospitalcollaborator
- Peking University Shenzhen Hospitalcollaborator
- Shenzhen People's Hospitalcollaborator
Study Sites (1)
UHongKongShenzhen
Shenzhen, Guangdong, China
Related Publications (1)
Zhao CN, Chiang CL, Chiu WK, Chan SK, Li CJ, Chen WW, Zheng DY, Chen WQ, Ji R, Lo CM, Jabbour SK, Chan CA, Kong FS. Treatments of transarterial chemoembolization (TACE), stereotactic body radiotherapy (SBRT) and immunotherapy reshape the systemic tumor immune environment (STIE) in patients with unresectable hepatocellular carcinoma. J Natl Cancer Cent. 2024 Nov 28;5(1):38-49. doi: 10.1016/j.jncc.2024.06.007. eCollection 2025 Feb.
PMID: 40040869DERIVED
Biospecimen
Whole blood, tissue, feces and body fluids such as urine, saliva, pleural effusion, ascites, and cranial spinal fluid
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Feng-Ming (Spring) KONG, Professor
The University of Hong Kong-Shenzhen Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Tenured Clinical Professor
Study Record Dates
First Submitted
May 21, 2021
First Posted
September 29, 2021
Study Start
June 27, 2019
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
January 27, 2026
Record last verified: 2026-01