CancerRegistryNCT02070328
Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
An observational study of Cancer, run by Center for Biomedical Research, LLC at 3 sites in United States.
Trial summary
Proton therapy is a limited medical resource that is more expensive than conventional x-ray therapy. To correctly measure the success of proton therapy in treating different conditions, it is important to check a patient's health status after their treatment is finished. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Registry
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2013to Jan 2050
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are seen/treated at proton therapy centers
Who may be able to join
- All subjects who are receiving or seeking medical care at the participating Proton Therapy Center will be invited to participate in the Research Registry.
Who cannot join
- Subjects who do not agree to participate
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Provision CARES Proton Therapy Nashville
Franklin, Tennessee, 37067
Kristi Simcox, BS, CCRP, 865-934-2672, kristi.simcox@biomed-research.com
James Gray, MD
- Recruiting
Texas Center for Proton Therapy
Irving, Texas, 75063
Vanetta G. Zollicoffer, CCRC, 469-513-5531, Vanetta.Zollicoffer@usoncology.com
Andrew K. Lee, MD
- Recruiting
Ackerman Cancer Center
Jacksonville, Florida, 32223
Michele Katz, CRC, 904-880-5522, michelek@ackermancancer.com
Cate Bernatt, CRA, 904-880-5522, cateb@ackermancancer.com
About this study
Proton therapy is a limited medical resource that is more expensive than conventional x-ray therapy. To correctly measure the success of proton therapy in treating different conditions, it is important to check a patient's health status after their treatment is finished. Checking on the progress of patients over many years (called long-term follow-up) is needed because the long-term effects of proton therapy are not well known.
Read the detailed description
The objective of this research protocol is the development of a national Proton Therapy Center Registry for the purpose of:
- Performing retrospective research studies on diseases treated with proton therapy throughout the United States.
- Maintaining regular, lifetime contact with subjects in order to obtain current identification , contact information, and self/parent-reported health status in order to obtain a better understanding of overall treatment strategies and patient benefits of treatment.
- Permitting review of medical record information contained within the Registry to identify subjects who may be eligible for participation in future research studies conducted at the Proton Therapy Institution where the participant was treated. Obtaining the permission of Research Registry participants to be contacted to ascertain their interest in participating in future research studies being conducted at their participating Proton Therapy Institution for which it appears (i.e., based on medical information contained within the Research Registry) they may be eligible.
- Conditions
- Cancer
- Being tested
- Registry
- Keywords
- Proton Therapy, Registry
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy Registry | Cancer patients who have received proton therapy Receives: Other: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term follow-up
Maintaining regular, lifetime contact with subjects in order to obtain current identification , contact information, and self/parent-reported health status in order to obtain a better understanding of overall treatment strategies and patient benefits of treatment.
Measured: 6 months
Secondary outcomes (1)
Future Research Possibilities
Performing retrospective research studies on diseases treated with proton therapy throughout the United States.
Permitting review of medical record information contained within the Registry to identify subjects who may be eligible for participation in future research studies conducted at the Proton Therapy Institution where the participant was treated. Obtaining the permission of Research Registry participants to be contacted to ascertain their interest in participating in future research studies being conducted at their participating Proton Therapy Institution for which it appears (i.e., based on medical information contained within the Research Registry) they may be eligible.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2050 (estimated)
- Study completionJan 2050 (estimated)
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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- Center for Biomedical Research, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Provision Center for Proton Therapy
- Responsible party
- Sponsor
- Investigators
- James R Gray, M.D., Principal investigator, Provision Center for Proton Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070328
- Sponsor's protocol ID
- PRO 0425
- Acronym
- Registry
- Status last verified
- Feb 2023
- First submitted
- 14 Jan 2014
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
- ClinicalTrials.gov ID
- NCT02070328
- Acronym / sponsor ID
- Registry / PRO 0425
- Conditions
- Cancer
- Keywords
- Proton Therapy, Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Center for Biomedical Research, LLCUniversity, hospital or other
- Collaborators
- Provision Center for Proton Therapy
- Study start
- Dec 2013
- Primary completion
- Jan 2050 (estimated)
- Study completion
- Jan 2050 (estimated)
- First posted
- 25 Feb 2014 (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.
Proton therapy is a limited medical resource that is more expensive than conventional x-ray therapy. To correctly measure the success of proton therapy in treating different conditions, it is important to check a patient's health status after their treatment is finished. Checking on the progress of patients over many years (called long-term follow-up) is needed because the long-term effects of proton therapy are not well known.
Detailed description
The objective of this research protocol is the development of a national Proton Therapy Center Registry for the purpose of:
- Performing retrospective research studies on diseases treated with proton therapy throughout the United States.
- Maintaining regular, lifetime contact with subjects in order to obtain current identification , contact information, and self/parent-reported health status in order to obtain a better understanding of overall treatment strategies and patient benefits of treatment.
- Permitting review of medical record information contained within the Registry to identify subjects who may be eligible for participation in future research studies conducted at the Proton Therapy Institution where the participant was treated. Obtaining the permission of Research Registry participants to be contacted to ascertain their interest in participating in future research studies being conducted at their participating Proton Therapy Institution for which it appears (i.e., based on medical information contained within the Research Registry) they may be eligible.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 25 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy Registry | – | Other: RegistryCancer patients who have received proton therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are seen/treated at proton therapy centers
Key inclusion criteria (1 listed)
- All subjects who are receiving or seeking medical care at the participating Proton Therapy Center will be invited to participate in the Research Registry.
Key exclusion criteria (1 listed)
- Subjects who do not agree to participate
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 |
|---|---|---|
| Registry | Other | Radiation therapy Registry |
Primary outcome
Long-term follow-up
Time frame: 6 months
Maintaining regular, lifetime contact with subjects in order to obtain current identification , contact information, and self/parent-reported health status in order to obtain a better understanding of overall treatment strategies and patient benefits of treatment.
1 secondary outcome
Future Research Possibilities
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Provision Center for Proton TherapyLink 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.
James R Gray, M.D. principal investigator
Provision Center for Proton Therapy
3 sites 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 Center for Biomedical Research, LLC at 3 sites 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 1 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: looking for participants now, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristi Simcox, BS, CCRP ((865) 934-2672, kristi.simcox@biomed-research.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term follow-up (time frame: 6 months). 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 8 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.