CancerTQ-BIRDNCT05061342
Tumor Control, Treatment Toxicity, Quality of Life and Bio-Imaging Repository Databank (TQ-BIRD) for Cancer Patients
An observational study of Cancer, run by Fengming Kong at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2019to 31 Dec 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- Participants who have supposedly limited ability to complete the survey questionnaires of the present study will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
UHongKongShenzhen
Shenzhen, Guangdong
Feng-Ming (Spring) KONG, Professor, 0755-86913333-2997, kong0001@hku.hk
About this study
Official 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
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).
Read the detailed description
The primary biomarkers of our interest are those obtained from minimally invasive procedures and those associated with immune/inflammatory treatment responses such as lymphocyte count, immune cell subtype distribution, TGF-beta1, immunomodulating interleukins and IDO metabolites. We will measure the biomarkers pre-, during- and post-anticancer treatment for hypothesis driven studies, and bank residual biological specimen, in combination with prospectively collected data including patient/tumor/treatment factors, imaging, tumor control outcome, treatment toxicity and QOL measures. We will classify the tumor response according to RECIST criteria and qualify QoL by using the PROMIS grading system and correlate them with the corresponding biomarkers. This study will serve young investigators who are interested in biomarker studies for early diagnosis, tumor control outcome and treatment toxicity/QOL prediction, aiming to guide personalized cancer care in future.
- Conditions
- Cancer
- Being tested
- No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.
- Keywords
- surgery, systemic therapy, radiotherapy, biomarker, imaging, toxicity, quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.Other
Also called 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.
Any anticancer or palliative care
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patients | Those with cancer. Receives: Other: No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care. | |
| Normal (non cancer) controls | Those without cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start27 Jun 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fengming Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Taizhou Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor-investigator, Fengming Kong, The University of Hong Kong-Shenzhen Hospital
- Investigators
- Feng-Ming (Spring) KONG, Professor, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061342
- Sponsor's protocol ID
- GCOG0001
- Acronym
- TQ-BIRD
- Status last verified
- Jan 2026
- First submitted
- 21 May 2021
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40040869
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05061342
- Acronym / sponsor ID
- TQ-BIRD / GCOG0001
- Conditions
- Cancer
- Keywords
- surgery, systemic therapy, radiotherapy, biomarker, imaging, toxicity, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Fengming KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Taizhou Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The primary biomarkers of our interest are those obtained from minimally invasive procedures and those associated with immune/inflammatory treatment responses such as lymphocyte count, immune cell subtype distribution, TGF-beta1, immunomodulating interleukins and IDO metabolites. We will measure the biomarkers pre-, during- and post-anticancer treatment for hypothesis driven studies, and bank residual biological specimen, in combination with prospectively collected data including patient/tumor/treatment factors, imaging, tumor control outcome, treatment toxicity and QOL measures. We will classify the tumor response according to RECIST criteria and qualify QoL by using the PROMIS grading system and correlate them with the corresponding biomarkers. This study will serve young investigators who are interested in biomarker studies for early diagnosis, tumor control outcome and treatment toxicity/QOL prediction, aiming to guide personalized cancer care in future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients | – | Other: No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.Those with cancer. |
| Normal (non cancer) controls | – | –Those without cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who have supposedly limited ability to complete the survey questionnaires of the present study will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.Also: 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.Any anticancer or palliative care | Other | Cancer Patients |
Primary outcome
Tumor control, treatment toxicity, quality of life
Time frame: 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.
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.
1 secondary outcome
Bio-Imaging-Repository-Databank (BIRD)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Derived from this study: PubMed 40040869Zhao 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng-Ming (Spring) KONG, Professor principal investigator
The University of Hong Kong-Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Fengming Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li YANG, Dr. (0755-86913333-2107, yangl1@hku-szh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor control, treatment toxicity, quality of life (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05061342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.