Precise Therapy for mCRPC Patients Through Whole Exome Sequencing(PTtWES)

NCT04126915 | Unknown

• 1 other identifier: mCRPC-WES2019
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Through gene sequencing of the patient's tissue, to figure out the genomic characteristics of patients with advanced disease and guide the treatment of patients

Conditions

Castration-Resistant Prostatic Cancer

Keywords

Castration-Resistant Prostatic Cancer; Whole Exome Sequencing

Outcome Measures

Primary Outcomes (1)

• The genetic characteristics of mCRPC patients in China

  The genetic characteristics of mCRPC patients in China as Assessed by Gene Sequencing

  June 2020

Secondary Outcomes (2)

• the possible prognostic therapeutic target

  June 2023

• The best method to treat the disease

  June 2023

Interventions

Whole Exome Sequencing GENETIC

Whole Exome Sequencing of the patient's primary tumor, metastases

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Male patient with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The enrolled patients were mCRPC patients with measurable and retrievable metastases.

You may qualify if:

• Expected survival period ≥ half a year;
• Whole body bone scan (ECT) and magnetic resonance imaging (MRI) or PET-CT are evaluated as metastatic castration to resist prostate cancer patients;
• Patients with evaluable and retrievable lesions;
• Patients who voluntarily receive the experimental study protocol after informing the existing treatment plan;

You may not qualify if:

• Patients with other malignancies, or in acute infection or other severe infections; immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or syphilis-positive patients;
• Patients who have long-term anticoagulant and anti-platelet aggregation drugs (the anticoagulant is discontinued for less than 1 week);
• At the same time suffering from other serious systemic diseases, the researchers believe that it may interfere with the treatment, evaluation and compliance of this test, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary and other systems. disease;
• The patient that it is inappropriate to participate in this clinical trial

Sponsors & Collaborators

• Yinghao Sun: lead

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens are metastatic tissues of patients, including bone metastases and metastatic lymph nodes

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

Exome Sequencing

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Whole Genome Sequencing; Sequence Analysis, DNA; Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• yinghao sun, PHD

  Department of Urology，Changhai Hospital of Second Military Medical University

  STUDY CHAIR

Central Study Contacts

jing li, PHD

CONTACT

+81-15801966205; drlijing@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,Clinical Professor

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 15, 2019
• Study Start: November 8, 2019
• Primary Completion: October 8, 2022
• Study Completion: October 8, 2024
• Last Updated: November 5, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share