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NCT02981797 · ClinicalTrials.gov registry record

Assess Gamma H2AX Positivity in Circulating Prostate Cancer Cells Before and After Radium 223

A clinical trial, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
10
Enrollment target

NCT02981797: Completed study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT02981797 is a clinical trial that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02981797 has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
10 participants
Enrollment target

Study Summary

This is a prospective biomarker study on prostate cancer patients receiving Radium 223 as standard of care. Participants will take part in this research study because they have chosen Radium 223 treatment for their prostate cancer that has spread to the bone and causing pain. Investigators want to find out if a blood test performed before and after the Radium 223 treatment will help to understand how prostate cancer cells react to this therapy. In this pilot study, researchers want to find out if Radium 223 given as part of standard treatment for prostate cancer can decrease the number of circulating prostate cancer cells. Radium 223 kills prostate cancer cells by damaging their DNA. Other than looking at the changes in the number of circulating prostate cancer cells before and after Radium 223, researchers would also like to look at the changes in a DNA damage marker, called gamma H2AX, in the circulating prostate cancer cells before and after treatment with Radium 223. Assessing the DNA damage marker gamma H2AX is investigational. It is performed in the same tube of blood that is used for assessing the changes in the number of circulating prostate cancer cells.

Primary Outcome

Assess changes in gamma H2AX positivity in circulating prostate cancer cells before and after Radium 223 treatment. CTC numeration, the gamma-H2AX detection and interpretation will be performed by Veridex with the cell search platform.

Interventions

  • OTHER Blood Collection During Standard of Care Treatment

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2015-07-22
Est. Completion 2020-11-05

What the finished NCT02981797 record still lists

NCT02981797 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Blood Collection During Standard of Care Treatment is the first listed.

NCT02981797 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02981797 about?

NCT02981797 is a clinical study titled "Assess Gamma H2AX Positivity in Circulating Prostate Cancer Cells Before and After Radium 223". This is a prospective biomarker study on prostate cancer patients receiving Radium 223 as standard of care. Participants will take part in this research study because they have chosen Radium 223 treatment for their prostate cancer that has spread to the bone and causing pain. Investigators want to ...

What is the current status of trial NCT02981797?

This trial is currently completed. The enrollment target is 10 participants. The study started on 2015-07-22. Estimated completion is 2020-11-05.

What interventions are being tested in trial NCT02981797?

The interventions under investigation include: Blood Collection During Standard of Care Treatment (OTHER).

Who is sponsoring clinical trial NCT02981797?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02981797, the US trial registry maintained by the National Library of Medicine. NCT02981797 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.