Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multi-omics Study of Metastatic Prostate Cancer (MOSMPCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04660617
Recruitment Status : Not yet recruiting
First Posted : December 9, 2020
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Hao Zeng, West China Hospital

Brief Summary:
The investigators plan to perform multi-omics technologies, including genomic, transcriptomic, epigenomic and proteomic methods, in patients with metastatic prostate cancer, aiming at uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets.

Condition or disease
Prostate Cancer Metastatic

Detailed Description:

Prostate cancer is the commonest malignancy and the second leading cause of tumor-related death among males worldwide. Though patients with early stage prostate cancer can obtain satisfactory therapeutic efficacy from radical prostatectomy or radiotherapy, the prognosis of men with metastatic prostate cancer (mPCa), especially metastatic castration-resistant prostate cancer (mCRPC), is still poor. Recent years have witnessed the rapid development of the high-throughput technologies, including genomic, transcriptomic, epigenomic and proteomic methods. These techniques are promising in uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets.

In the current prospective study, the investigators plan to perform multi-omics technologies in patients with mPCa, aiming at uncovering the mechanism of the tumor progression, identifying distinct tumor subtypes and finding new treatment targets.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Multi-omics Study of Metastatic Prostate Cancer (MOSMPCA)
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Genetic profiling results [ Time Frame: From baseline (initial diagnosis of PCa), until study completion (48 months) ]
    Mutation identified via whole-genome sequencing will be recored.

  2. Transcriptional profiling results [ Time Frame: From baseline (initial diagnosis of PCa), until study completion (48 months) ]
    Determining the transcriptomic information of metastatic prostate cancer by performing whole transcriptome sequencing

  3. Epigenomic profiling results [ Time Frame: From baseline (initial diagnosis of PCa), until study completion (48 months) ]
    Determining the epigenomic status of specific genes by performing DNA-methylation sequencing


Secondary Outcome Measures :
  1. Protein expression results [ Time Frame: From baseline (initial diagnosis of PCa), until study completion (48 months) ]
    Determing the expression status of centain proteins by performing immunohistochemistry in prostate biopsy specimen



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male patient can enter this study
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary metastatic prostate cancer are potentially eligible for the current study.
Criteria

Inclusion Criteria:

  • Pathological confirmation of prostate cancer
  • Age: ≥40 years old
  • Bone or visceral metastatic disease confirmed by image examination.
  • Written informed consent

Exclusion Criteria:

  • Patients harbouring other types of cancer besides prostate cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660617


Contacts
Layout table for location contacts
Contact: Jinge Zhao, Dr. 86 13679017572 jingezhao@foxmail.com

Sponsors and Collaborators
West China Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hao Zeng, Dr. West China Hospital
Layout table for additonal information
Responsible Party: Hao Zeng, Vice director of the department of urology, West China Hospital
ClinicalTrials.gov Identifier: NCT04660617    
Other Study ID Numbers: MOSMPCA
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hao Zeng, West China Hospital:
Genomic sequencing
Transcriptome sequencing
Epigenetics
Metabonomics
Immunohistochemical
Multi-omics Study
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases