RadiationNCT01099020
Temporal Pattern of Circulating DNA for Patients Receiving Irradiation
An observational study of Radiation, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of the research study is to test a measurement tool that will determine the radiation dose people receive when they have been accidentally exposed to radiation. This test will be done using a small amount of blood and known dose of radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving large volume of radiation for the treatment of their cancer
Who may be able to join
- Patient must be scheduled to undergo Total Body Irradiation (TBI) as part of a conditioning regime for a Bone Marrow Transplant. OR, Be scheduled to undergo Radiation Therapy treatment for a malignancy or other disease and have a radiation treatment field that contains at least 2 liters of tissue receiving at least 2 Gy radiation dose over the first 5 days of treatment.
- Patient must be willing to have blood draws as defined below.
- Patient must provide study-specific informed consent prior to study entry.
- Hemoglobin≥8.
- Age ≥ 18, but not older than age 60.
Who cannot join
- Patients not meeting the above inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Pattern of Circulating DNA for Patients Receiving Total Body Irradiation
The purpose of the research study is to test a measurement tool that will determine the radiation dose people receive when they have been accidentally exposed to radiation. This test will be done using a small amount of blood and known dose of radiation.
- Conditions
- Radiation
- Keywords
- Subjects receiving large volumes of Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Funding for project was withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Milano, MD,PhD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099020
- Sponsor's protocol ID
- ULAB10008
- Status last verified
- May 2015
- First submitted
- 2 Apr 2010
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Pattern of Circulating DNA for Patients Receiving Total Body Irradiation
- ClinicalTrials.gov ID
- NCT01099020
- Acronym / sponsor ID
- ULAB10008
- Conditions
- Radiation
- Keywords
- Subjects receiving large volumes of Radiation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding for project was withdrawn
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research study is to test a measurement tool that will determine the radiation dose people receive when they have been accidentally exposed to radiation. This test will be done using a small amount of blood and known dose of radiation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving large volume of radiation for the treatment of their cancer
Key inclusion criteria (5 listed)
- Patient must be scheduled to undergo Total Body Irradiation (TBI) as part of a conditioning regime for a Bone Marrow Transplant. OR, Be scheduled to undergo Radiation Therapy treatment for a malignancy or other disease and have a radiation treatment field that contains at least 2 liters of tissue receiving at least 2 Gy radiation dose over the first 5 days of treatment.
- Patient must be willing to have blood draws as defined below.
- Patient must provide study-specific informed consent prior to study entry.
- Hemoglobin≥8.
- Age ≥ 18, but not older than age 60.
Key exclusion criteria (1 listed)
- Patients not meeting the above inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Funding for project was withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding for project was withdrawn). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.