Clinical trial NCT05754983: Risk Factors and Long-term Impact of ICIs
Official title: To Evaluate the Prognostic Risk Factors and Long-term Health Effects of Immunotherapy Patients Based on the Specific Disease Cohort Registered With Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Malignant Neoplasm
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The included population is malignant solid tumor patients receiving immunotherapy for the first time

Brief summary: 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 events and health status to build a disease cohort database based on patient reports, and then analyze the risk factors affecting the efficacy, prognosis and adverse events 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 events after immunotherapy, and the further improvement of survival prognosis of patients

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, prognosis and adverse events of immunotherapy and the impact of immunotherapy on health status. We also retrospectively collected some data from medicine records for validation. The outcome indicators are mainly disease free progression survival (PFS), The secondary indicators were the total survival period (OS), objective response rate (ORR), immune-related adverse events (irAEs) 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 events after immunotherapy, and the further improvement of survival prognosis of patients.

Eligibility criteria: 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;
* 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

Primary outcomes:
measure: Progression-Free-Survival (PFS)
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospitap of Xian Jiaotong University
state: Shanxi
Study officials:
References: