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NCT Number: NCT05061342

Tumor Control, Treatment Toxicity, Quality of Life and Bio-Imaging Repository Databank (TQ-BIRD) for Cancer Patients

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).

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.

Other

Any anticancer or palliative care

Other names: 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Li YANG, Dr.

CONTACT

[email protected]

0755-86913333-2107

Sponsors and collaborators

Lead sponsor

Fengming Kong

Other

Collaborators

  • Peking University Shenzhen Hospital
  • Queen Mary Hospital, Hong Kong
  • Shenzhen People's Hospital
  • Taizhou Hospital
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study 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

Acronym: TQ-BIRD

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Sep 29, 2021
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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