Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04263935
Collaborator
(none)
200
1
95.6
2.1

Study Details

Study Description

Brief Summary

Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This trial is a prospective non-interventional observational study. The Chinese patients with lymphoma were included and the study data on driver gene abnormalities, demographic characteristics, clinicopathological characteristics and treatment were collected to evaluate the relevance of efficacy and disease prognosis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma
    Actual Study Start Date :
    Feb 14, 2020
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of driver gene abnormalities [from the day of the first patient was included to the date of the end of this trial, assessed up to 36 months]

      the incidence of driver gene abnormalities by fixed gene testing technology

    Secondary Outcome Measures

    1. objective response rate [from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months]

      the total proportion of patients with complete response (CR) and partial response (PR)

    2. 5-year overall survival [from the date of the first patient was included to the date of the end of this trial, assessed up to 5 years]

      from the date of first patient was included to the date of death by any cause

    3. Clinicopathological Characteristics [from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months]

      study data on clinicopathological characteristics related to incidence of driver gene abnormalities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Diagnosed as lymphoma (according to WHO 2017 classification criteria)

    2. Life expectancy no less than 3 months

    3. Agreeing to sign the written informed consents

    Exclusion Criteria:
    1. Other malignant tumor history or active malignant tumor need be treated

    2. Researchers determine unsuited to participate in this trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university Zhengzhou Henan China

    Sponsors and Collaborators

    • Henan Cancer Hospital

    Investigators

    • Study Director: Yanyan Liu, M.D. Ph.D, Henan Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanyan Liu, Director, Henan Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT04263935
    Other Study ID Numbers:
    • HNCH2019341
    First Posted:
    Feb 11, 2020
    Last Update Posted:
    Aug 17, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yanyan Liu, Director, Henan Cancer Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2021