Cancer DNA Detection in Blood and Urine

NCT02657863 | Completed DMC

• 2 other identifiers: J14106IRB00043215
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to collect and analyze biospecimens (blood and urine) and clinical data from patients with prostate cancer as well as healthy volunteers to better understand the differences between cancer cells and normal tissues with the goal of developing a better way to detect and track the treatment of prostate cancer.

• These samples are being collected to conduct research to accomplish the goal of improving cancer therapies, biomarkers, and hopefully lead to more effective treatment of prostate cancer.
• The samples that you are providing as a patient with prostate cancer will be used in future research.
• Your biospecimens will be compared to the cancer and normal volunteer specimens from other participants to understand genetic differences between normal and cancer cells. Genetic material, including DNA and RNA, will be obtained from samples, stored, and used for evaluation.
• Clinical information and samples will be collected and stored for ongoing research. This is a necessity because improved diagnosis, prognosis and treatment of cancer in the future depend upon the ongoing analysis of basic research findings and clinical outcomes. This type of research may improve the lives of future patients with cancer. Men between the ages of 18 and 100 with a diagnosis of cancer undergoing standard therapy with radiation may join.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Healthy volunteer baseline

  Establish the background reference range for cancer specific DNA methylation and structural alterations in urine and plasma from normal individuals.

  day 1

• DNA alterations in blood and urine during radiation therapy

  Examine cancer-specific DNA methylation and structural alterations in urine and plasma during and after fractionated radiation therapy for men with high-risk prostate cancer.

  blood and urine draw at baseline, week 8 of treatment and then at week 16 of treatment

Study Arms (3)

Healthy volunteer

Normal volunteers will be enrolled and informed consent obtained per study guidelines as described. Urine and plasma will be collected from each of 30 subjects with no prior history of prostate or other cancers.

Prostate cancer patients being treat with radiation therapy

Prostate cancer patients will be enrolled and informed consent obtained per study guidelines as described. We will collect urine and plasma samples from 25 consecutive men being treated with radiation therapy for high-risk prostate cancer prior to the onset of therapy.

Prostate cancer patients being treated with radiation therapy

Prostate cancer patients will be enrolled and informed consent obtained per study guidelines as described. We will collect urine and plasma samples from 5 consecutive men being treated with radiation therapy for high-risk prostate cancer prior to initiation of androgen deprivation (week 0), again prior to initiation of radiotherapy (week 8), at the end of radiation therapy (week 16) and at 6 months and 12 months after the conclusion of radiation therapy.

Procedure: Urine collection and blood draw

Interventions

Urine collection and blood draw PROCEDURE

Prostate cancer patients being treated with radiation therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and men with prostate cancer

You may qualify if:

• Male older than or equal to 18 years of age, but not older than 100 years of age.
• Signed informed consent prior to initiation of any study-related procedures.
• Minorities are included in this protocol.
• Signed informed consent prior to initiation of any study-related

You may not qualify if:

• It is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo procedures outlined in this protocol.
• Persons who are incarcerated are not eligible to participate.
• Women are not eligible.
• Persons incapable of providing informed consent are not eligible.
• Any person with a personal history of prior malignancy is not eligible
• Persons with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome are not eligible.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Patrick C Walsh Prostate Cancer Research Fund: collaborator

Study Sites (1)

Johns Hopkins SKCCC

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and Blood

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Urine Specimen Collection; Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Theodore DeWeese, M.D.

  Johns Hopkin SKCCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: January 18, 2016
• Study Start: November 1, 2014
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)