NeoplasmsNCT00178308
Measuring Alterations of DNA in Human Blood
An observational study of Neoplasms, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this research is to evaluate an automated, laser-based technique for measuring DNA damge resulting from radiation. We want to use controlled exposure on cancer patients to help develop a measurement to test people who may have been accidentally exposed to radiation. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Neoplasms
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 21 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female, age 21 to 70 years old.
- Patient undergoing with anti-neoplastic agent(s) known to have genotoxic activity (e.g., cyclophosphamide, 5-FU, cisplatin, Ara-C.
- X-irradiation may be considered, so long as a substantial fraction of red marrow is exposed (e.g., femur or chest/trunk region);
- treatment could be ongoing therapy or initial therapy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to evaluate an automated, laser-based technique for measuring DNA damge resulting from radiation. We want to use controlled exposure on cancer patients to help develop a measurement to test people who may have been accidentally exposed to radiation.
- Conditions
- Neoplasms
- Medical subject headings
- Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Litron Laboratories
- Investigators
- Yuhchyau Chen, MD, Ph.D, Principal investigator, Universtiy of Rochester, Dept of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178308
- Sponsor's protocol ID
- URCC 1702
- Status last verified
- Sep 2006
- First submitted
- 12 Sep 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Alterations of DNA in Human Blood
- ClinicalTrials.gov ID
- NCT00178308
- Acronym / sponsor ID
- URCC 1702
- Conditions
- Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Litron Laboratories
- First posted
- 15 Sep 2005 (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 this research is to evaluate an automated, laser-based technique for measuring DNA damge resulting from radiation. We want to use controlled exposure on cancer patients to help develop a measurement to test people who may have been accidentally exposed to radiation.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age 21 to 70 years old.
- Patient undergoing with anti-neoplastic agent(s) known to have genotoxic activity (e.g., cyclophosphamide, 5-FU, cisplatin, Ara-C.
- X-irradiation may be considered, so long as a substantial fraction of red marrow is exposed (e.g., femur or chest/trunk region);
- treatment could be ongoing therapy or initial therapy.
Key exclusion criteria (0 listed)
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
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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.
Yuhchyau Chen, MD, Ph.D principal investigator
Universtiy of Rochester, Dept of Radiation Oncology
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 Neoplasms, 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 11 Sep 2006. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 11 Sep 2006.