NCT04101305

Brief Summary

Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients? Is it possible to understand the causal relationship between the occurrence of the tumor cells and the tumor DNA in the blood by reviewing the patient's medical records, including information about investigations, analytical reports or diagnoses? Can gene defects that may be useful in predicting the best treatment be detected by sequencing individual tumor cells or plasma from blood samples?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

September 20, 2019

Last Update Submit

September 20, 2019

Conditions

Prostatic Neoplasms

Keywords

Prostate cancer, biomarker

Outcome Measures

Primary Outcomes (1)

  • Single cell DNA sampling

    Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients with various advanced disease?

    September 2019 to December 31st, 2020

Secondary Outcomes (2)

  • Comparison of novel sampling results to established biomarkers

    September 2019 to December 31st, 2020

  • Single cell DNA sequencing

    September 2019 to December 31st, 2020

Study Arms (4)

Localised prostate cancer

Patients diagnosed with prostate cancer of moderate estimated risk suitable for and scheduled for prostatectomy with gland evacuation

Diagnostic Test: IsoPic

Stage 3 prostate cancer

Patients with diagnosed stage 3 prostate cancer

Diagnostic Test: IsoPic

Stage 4 prostate cancer

Patients with diagnosed stage 4 prostate cancer

Diagnostic Test: IsoPic

Healthy controls

Age-matched healthy individuals free from diagnosed cancer, but with benign inflammatory prostatitis or other benign urological condition

Diagnostic Test: IsoPic

Interventions

IsoPicDIAGNOSTIC_TEST

Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Healthy controlsLocalised prostate cancerStage 3 prostate cancerStage 4 prostate cancer

Eligibility Criteria

Age18 Years - 125 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsGender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the urology clinic for investigation of a suspected urologic condition

You may qualify if:

  • patients diagnosed with prostate cancer of moderate risk planned for prostatectomy with lymph node removal, or
  • patients diagnosed with prostate cancer stage 3, or
  • patients with diagnosed prostate cancer stage 4, or
  • patients with diagnosed benign inflammatory prostatitis or other benign urological condition constituting age-matched, cancer free, controls

You may not qualify if:

  • Patients undergoing prostate cancer treatment (no prostate cancer treatment should be given to the patient before blood collection)
  • Patients with previous malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malarsjukhuset

Eskilstuna, Sormland, 631 88, Sweden

Location

Related Publications (3)

  • Castro et al., Surgery Curr Res 2012, 2:3 http://dx.doi.org/10.4172/2161-1076.1000113

    BACKGROUND

  • Castro et al., J Integr Oncol 2018, 7:3 DOI: 10.4172/2329-6771.1000212

    BACKGROUND

  • Castro et al., Disease Markers Volume 2018, Article ID 4653109, 5 pages https://doi.org/10.1155/2018/4653109

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Evangelos Digkas, MD, PhD

    Region Sormland

    STUDY DIRECTOR

Central Study Contacts

Ninos Oussi, MD

CONTACT

+4616103000ninos.oussi@ki.se

Evangelos Digkas, MD, PhD

CONTACT

+46728598648Evangelos.Digkas@regionsormland.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior scientist

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 24, 2019

Study Start

September 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers

Locations

SE(1)