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

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).

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Li YANG, Dr.; Phone Number: 0755-86913333-2107; Email: yangl1@hku-szh.org

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • UHongKongShenzhen
      • Contact: Feng-Ming (Spring) KONG, Professor; Phone Number: 0755-86913333-2997; Email: kong0001@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer Patients; Those with cancer.	Other: No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.; Any anticancer or palliative care; Other Names: 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Fengming Kong
• Collaborators: The University of Hong Kong
• Investigators: Principal Investigator: Feng-Ming (Spring) KONG, Professor, The University of Hong Kong-Shenzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Anticipated): June 14, 2024
• Study Completion (Anticipated): October 14, 2024

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: imaging; quality of life; radiotherapy; biomarker; surgery; toxicity; systemic therapy
• Other Study ID Numbers: GCOG0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No