CancerNCT00581958
Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)
An observational study of Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Read more about this study
- Who is it for?
- Ages 4 to 100 years
- Conditions the study is for
- Cancer
- What is being tested?
- Blood Samples
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to 31 Oct 2018
- 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 4 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential research subjects will be identified by the primary Radiation Oncologist whom the patient is referred to by the Adult or Pediatric Bone Marrow Transplant Service.
Who may be able to join
- Patients greater than 4 years of age at Memorial Sloan-Kettering Cancer Center
- Must be undergoing hematopoietic stem cell transplantation (either autologous or allogenic) in conjunction with a conditioning regimen that includes TBI (single or multiple fraction)
- Functional central venous catheter
Who cannot join
- No subjects will be excluded from the proposed research study for demographic reasons. Treatment with growth factors, such as keratinocyte growth factor (KGF), will not be grounds for exclusion.
- Subjects who will receive radiation therapy within 5 days prior to TBI will be excluded.
- Subjects who will receive systemic antineoplastic chemotherapy within 7 days prior to TBI not have research bloods collected. Only urine will be collected from these patients.
- Based on current knowledge, we will not a priori exclude patients based on disease status (ie, patients in or out of remission will be included in this study), type of disease(ie, chromosomal breakage syndromes), or previous therapies (unless exclusion criteria is met).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Radiation treatment machines are programmed to give exact doses of radiation.
Read the detailed description
MSKCC patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have blood drawn and urine collected for use in the validation and refinement of new methods for rapid high-throughput radiation biodosimetry. These blood and urine samples will be collected before, and at defined times after TBI. Blood sampling will occur in the same manner that it does during routine patient care during HSCT.
- Conditions
- Cancer
- Being tested
- Blood Samples
- Keywords
- total body irradiation, Cancer, Hematopoietic System
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplesOther
blood (approximately two 4 ml; equivalent to less than 2 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing HSCT | Research subjects will have blood and/or urine sampled at three time points in the Department of Radiation Oncology. Participating patients will have at least a total two samples collected at each time point. The first sampling will occur before the first TBI treatment is given. The second sampling will occur before the second TBI treatment, usually 3 to 8 hours after the first treatment (in the case of multifraction TBI). If a patient is being treated with single fraction TBI, then the second sampling will occur approximately 3-8 hours after the first TBI treatment. The third and final sampling will occur at the next morning blood draw, prior to the fourth TBI treatment (in the case of multifraction TBI), 24 hours after the first TBI treatment. Receives: Other: Blood Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays.
The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startNov 2007
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University, National Institute of Standards and Technology
- Responsible party
- Sponsor
- Investigators
- Christopher Barker, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581958
- Sponsor's protocol ID
- 07-158
- Status last verified
- Nov 2018
- First submitted
- 21 Dec 2007
- Last updated
- 5 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)
- ClinicalTrials.gov ID
- NCT00581958
- Acronym / sponsor ID
- 07-158
- Conditions
- Cancer
- Keywords
- total body irradiation, Cancer, Hematopoietic System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Georgetown University, National Institute of Standards and Technology
- Study start
- Nov 2007 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 28 Dec 2007 (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 study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Radiation treatment machines are programmed to give exact doses of radiation.
Detailed description
MSKCC patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have blood drawn and urine collected for use in the validation and refinement of new methods for rapid high-throughput radiation biodosimetry. These blood and urine samples will be collected before, and at defined times after TBI. Blood sampling will occur in the same manner that it does during routine patient care during HSCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing HSCT | – | Other: Blood SamplesResearch subjects will have blood and/or urine sampled at three time points in the Department of Radiation Oncology. Participating patients will have at least a total two samples collected at each time point. The first sampling will occur before the first TBI treatment is given. The second sampling will occur before the second TBI treatment, usually 3 to 8 hours after the first treatment (in the case of multifraction TBI). If a patient is being treated with single fraction TBI, then the second sampling will occur approximately 3-8 hours after the first TBI treatment. The third and final sampling will occur at the next morning blood draw, prior to the fourth TBI treatment (in the case of multifraction TBI), 24 hours after the first TBI treatment. |
Who may qualify
- Ages
- 4 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential research subjects will be identified by the primary Radiation Oncologist whom the patient is referred to by the Adult or Pediatric Bone Marrow Transplant Service.
Key inclusion criteria (3 listed)
- Patients greater than 4 years of age at Memorial Sloan-Kettering Cancer Center
- Must be undergoing hematopoietic stem cell transplantation (either autologous or allogenic) in conjunction with a conditioning regimen that includes TBI (single or multiple fraction)
- Functional central venous catheter
Key exclusion criteria (4 listed)
- No subjects will be excluded from the proposed research study for demographic reasons. Treatment with growth factors, such as keratinocyte growth factor (KGF), will not be grounds for exclusion.
- Subjects who will receive radiation therapy within 5 days prior to TBI will be excluded.
- Subjects who will receive systemic antineoplastic chemotherapy within 7 days prior to TBI not have research bloods collected. Only urine will be collected from these patients.
- Based on current knowledge, we will not a priori exclude patients based on disease status (ie, patients in or out of remission will be included in this study), type of disease(ie, chromosomal breakage syndromes), or previous therapies (unless exclusion criteria is met).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Samplesblood (approximately two 4 ml; equivalent to less than 2 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment. | Other | Patients undergoing HSCT |
Primary outcome
To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays.
Time frame: 3 years
The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.
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 5 Nov 2018.
- Memorial Sloan Kettering Web SiteLink provided by the sponsor.
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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.
Christopher Barker, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Cancer, run by Memorial Sloan Kettering Cancer Center 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 3 inclusion and 4 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 5 Nov 2018. 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?
To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays. (time frame: 3 years). 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 5 Nov 2018.