CancerNCT01050725
Pilot Study of Biomarkers for Radiation Therapy
An observational study of Cancer, run by Benaroya Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether specific assays of DNA damage repair proteins can be used in patients undergoing radiation therapy. The ultimate goal of this research is to develop clinically useful biomarkers from blood samples that could be used to customize radiation treatment for individuals… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2013
- 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 undergoing radiation for selected malignancies, including head and neck, lung, esophageal, rectal, cervical and prostate cancers.
Who may be able to join
- patients > 18 years of age with primary lung, esophageal or rectal cancer receiving neo-adjuvant chemoradiotherapy before planned resection
- patients with clinically localized prostate cancer receiving definitive radiation therapy with external beam treatment. brachytherapy as a boost and/or hormonal therapy are allowed.
- patients with head and neck, lung, esophageal or cervical cancer who will receive definitive radiotherapy
Who cannot join
- prior history of chemotherapy given within 6 months before enrollment.
- prior radiotherapy or radionuclide treatment and/or brachytherapy within 6 months prior to enrollment.
- unwillingness to comply with tests, protocol, or informed consent.
- concurrent enrollment on any protocol that would require non-compliance with treatment procedures.
- chemotherapy required within 2 hours following first dose of XRT.
- PET scan done within 48 hours of first blood draw.
- nuclear medicine exposure within 4 days prior to first draw.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98111
About this study
Official title: Investigating Proteomic Biomarkers of Radiation Therapy Outcome: A Pilot Study
The purpose of this study is to determine whether specific assays of DNA damage repair proteins can be used in patients undergoing radiation therapy. The ultimate goal of this research is to develop clinically useful biomarkers from blood samples that could be used to customize radiation treatment for individuals, leading to reduced side effects and improved outcomes.
- Conditions
- Cancer
- Keywords
- proteome, biomarkers, radiotherapy, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy patients | Individuals receiving radiation therapy as definitive or neo-adjuvant therapy for selected malignancies, including head and neck, lung, esophageal, rectal cervical and prostate cancers. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionJun 2013 (estimated)
Why it stopped: On hold: pending grant funding for further enrollment
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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center, Fred Hutchinson Cancer Center
- Investigators
- Kas R Badiozamani, MD, Principal investigator, Virginia Mason Hospital/Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050725
- Sponsor's protocol ID
- IRB09016
- Status last verified
- Jun 2011
- First submitted
- 13 Jan 2010
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Proteomic Biomarkers of Radiation Therapy Outcome: A Pilot Study
- ClinicalTrials.gov ID
- NCT01050725
- Acronym / sponsor ID
- IRB09016
- Conditions
- Cancer
- Keywords
- proteome, biomarkers, radiotherapy, cancer
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: On hold: pending grant funding for further enrollment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center, Fred Hutchinson Cancer Center
- Study start
- Nov 2009
- Primary completion
- Jun 2013 (estimated)
- First posted
- 15 Jan 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 this study is to determine whether specific assays of DNA damage repair proteins can be used in patients undergoing radiation therapy. The ultimate goal of this research is to develop clinically useful biomarkers from blood samples that could be used to customize radiation treatment for individuals, leading to reduced side effects and improved outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy patients | – | –Individuals receiving radiation therapy as definitive or neo-adjuvant therapy for selected malignancies, including head and neck, lung, esophageal, rectal cervical and prostate cancers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing radiation for selected malignancies, including head and neck, lung, esophageal, rectal, cervical and prostate cancers.
Key inclusion criteria (3 listed)
- patients > 18 years of age with primary lung, esophageal or rectal cancer receiving neo-adjuvant chemoradiotherapy before planned resection
- patients with clinically localized prostate cancer receiving definitive radiation therapy with external beam treatment. brachytherapy as a boost and/or hormonal therapy are allowed.
- patients with head and neck, lung, esophageal or cervical cancer who will receive definitive radiotherapy
Key exclusion criteria (7 listed)
- prior history of chemotherapy given within 6 months before enrollment.
- prior radiotherapy or radionuclide treatment and/or brachytherapy within 6 months prior to enrollment.
- unwillingness to comply with tests, protocol, or informed consent.
- concurrent enrollment on any protocol that would require non-compliance with treatment procedures.
- chemotherapy required within 2 hours following first dose of XRT.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
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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.
Kas R Badiozamani, MD principal investigator
Virginia Mason Hospital/Medical 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 Benaroya Research Institute 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 7 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: paused, as of the sponsor's last update on 30 Jun 2011. 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?
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 30 Jun 2011.