Clinical trial NCT05061342: Tumor Control, Treatment Toxicity, Quality of Life and Bio-Imaging Repository Databank (TQ-BIRD) for Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: surgery
systemic therapy
radiotherapy
biomarker
imaging
toxicity
quality of life
Lead sponsor: The University of Hong Kong-Shenzhen Hospital
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2021-09-29
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor control, treatment toxicity, quality of life
timeFrame: 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:
measure: Bio-Imaging-Repository-Databank (BIRD)
timeFrame: 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.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: UHongKongShenzhen
state: Guangdong
Study officials:
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Feng-Ming (Spring) KONG, Professor
role: PRINCIPAL_INVESTIGATOR
References: