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

Fengming Kong

Status: Enrolling

Conditions: Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT05061342

GCOG0001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

5,000 participants in 2 patient groups

Cancer Patients

Description:

Those with cancer.

Treatment:

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

Description:

Those without cancer.