NeoplasmsNCT00167427
Genotoxicity Assessment for Patients Undergoing Radiation Treatment
An observational study of Neoplasms, run by Yuhchyau Chen at 1 site in United States.
Trial summary
The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to 23 Feb 2024
- 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 that are scheduled to begin radiotherapy to the large-field chest region
Who may be able to join
- Patients that are scheduled to begin radiotherapy to the large-field chest region are eligible if:
- Daily radiation dose is between 1.8 and 5 Gy/day
- Any single dimension of field size is ≥ 15 cm
- Provision of written informed consent
- or
- Or patients receiving IMRT or Tomotherapy, when low-dose radiation is spread out to the normal tissues, irrespective of daily radiation doses.
- Or patients receiving radionucleotides as part of the medical treatment (cancer or non-malignant conditions)
- Or patients who will receive diagnostic CT scans, PET/CT scans, mammograms, or diagnostic imaging requiring radionucleotides
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, Dept. Radiation Oncology
Rochester, New York, 14642
About this study
Official title: Genotoxicity Assessment for Patients Receiving Large Field Irradiation
The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.
Read the detailed description
Correlative studies: analysis of RT effect on genotoxicity by assessing cytogenetic changes (dicentrics), micronucleated lymphocytes (MN-lymph), and micronucleated reticulocytes (MN-RET) using peripheral blood of patients receiving radiation.
- document the kinetics by which radiation-induced MN-RET enter the peripheral blood stream. ii) benchmark the MN-RET endpoint against current gold-standard biodosimetry endpoints-dicentrics and MN-lymphocytes. iii) measure inter-individual variation in baseline and radiation-induced MN-RET frequencies. iv) in collaboration with several FCM-equipped laboratories, evaluate the transferability of the human MN-RET scoring assay.
- Conditions
- Neoplasms
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the Change in MN-RET in the blood
Measured: Baseline and 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startApr 2006
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhchyau Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuhchyau Chen, University of Rochester
- Investigators
- Yuhchyau Chen, MD, Ph.D, Principal investigator, Universtiy of Rochester, Dept of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167427
- Sponsor's protocol ID
- URCC 3705
- Other IDs
- 1U19AI067733-01
- Status last verified
- Mar 2024
- First submitted
- 9 Sep 2005
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotoxicity Assessment for Patients Receiving Large Field Irradiation
- ClinicalTrials.gov ID
- NCT00167427
- Acronym / sponsor ID
- URCC 3705
- Conditions
- Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Yuhchyau ChenUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2006
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 14 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 the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.
Detailed description
Correlative studies: analysis of RT effect on genotoxicity by assessing cytogenetic changes (dicentrics), micronucleated lymphocytes (MN-lymph), and micronucleated reticulocytes (MN-RET) using peripheral blood of patients receiving radiation.
- document the kinetics by which radiation-induced MN-RET enter the peripheral blood stream. ii) benchmark the MN-RET endpoint against current gold-standard biodosimetry endpoints-dicentrics and MN-lymphocytes. iii) measure inter-individual variation in baseline and radiation-induced MN-RET frequencies. iv) in collaboration with several FCM-equipped laboratories, evaluate the transferability of the human MN-RET scoring assay.
Study design
- Observational model
- Cohort
- 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 that are scheduled to begin radiotherapy to the large-field chest region
Key inclusion criteria (8 listed)
- Patients that are scheduled to begin radiotherapy to the large-field chest region are eligible if:
- or
- Or patients receiving IMRT or Tomotherapy, when low-dose radiation is spread out to the normal tissues, irrespective of daily radiation doses.
- Or patients receiving radionucleotides as part of the medical treatment (cancer or non-malignant conditions)
- Or patients who will receive diagnostic CT scans, PET/CT scans, mammograms, or diagnostic imaging requiring radionucleotides
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
Measure the Change in MN-RET in the blood
Time frame: Baseline and 1 day
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 7 Mar 2024.
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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 Yuhchyau Chen 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 8 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 7 Mar 2024. 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.
What does the primary outcome measure?
Measure the Change in MN-RET in the blood (time frame: Baseline and 1 day). It is what the study was designed to measure, not a finding.
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 7 Mar 2024.