Construction of a Database of Prognostic Risk Factors and Quality of Life of Patients With Primary Solid Malignant Cancers Receiving Immunotherapy for the First Time Based on Questionnaire Survey

February 22, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

Evaluation of Prognostic Risk Factors and Long-term Health Impact of Immunotherapy Patients Based on Special Disease Cohort Registered by Patients

This study plans to conduct a multicenter, observable and controlled cohort study to solid-tumor patients with receiving immunotherapy and to collect information about their treatment related efficacy, adverse reactions and health status to build a prospective disease cohort database based on patient reports, and then analyze the risk factors affecting the efficacy and prognosis of immunotherapy and the impact of immunotherapy on health status.It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse reactions after immunotherapy, and the further improvement of survival prognosis of patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is intended to conduct a multicenter, observable and controlled cohort study in multiple clinical centers including the First Affiliated Hospital of Xi'an Jiaotong University to solid-tumor patients who received immunotherapy for the first time, The baseline information before treatment was collected (mainly including three collection methods, namely, patients' self filling information, physician assisted filling information, and medical record system import information. The information collected was mainly in the following aspects: demographic characteristics, tumor and anti-tumor information, gene testing information, blood sample collection information, and questionnaire evaluation information) and follow-up information after treatment (The collection method and content are the same as the baseline information.) Collect the relevant factors that may affect the treatment efficacy and prognosis of patients, build a prospective disease cohort database based on patient reports, and then analyze the risk factors that affect the efficacy and prognosis of immunotherapy and the impact of immunotherapy on health status. The outcome indicators are mainly disease free progression survival (PFS), The secondary indicators were the total survival period (OS) and the scoring results of various questionnaires (PHQ-9, etc).It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse reactions after immunotherapy, and the further improvement of survival prognosis of patients

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • First Affiliated Hospitap of Xian Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The included population is malignant solid tumor patients receiving immunotherapy for the first time

Description

Inclusion Criteria:

  • Age range of subjects: the age of subjects is no less than 18 years old;
  • Receiving any ICIs treatment or ICIs combined with other treatments;
  • Soild malignant tumor proved by pathology (histology or cytology);
  • First treatment with ICIs {including ICIs (first) combined with other treatments)};
  • Any stage and treatment line (new auxiliary, auxiliary and advanced treatment)
  • Willing to treat, and can come to the hospital regularly in the later period

Exclusion Criteria:

  • Previous medical history of other malignant tumors;
  • Liver/lung metastasis;
  • No pathology (histology or cytology) certificate;
  • Having received ICIs or other immunotherapy in the past;
  • Participated in clinical research in the past and may have applied ICIs or other immunotherapy;
  • Weak treatment intention or long-term treatment in other hospitals/departments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free-Survival (PFS)
Time Frame: Two years
It refers to the time from randomization to disease progression
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Estimate)

March 6, 2023

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022LSL-020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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