NCT02457962

Brief Summary

To collect and analyze specimens that will correlate with clinical outcomes such as acute and late toxicities, quality of life, local control, and survival of patients treated with photon/proton therapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Apr 2015Apr 2031

Study Start

First participant enrolled

April 23, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
15.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2031

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

16 years

First QC Date

May 11, 2015

Last Update Submit

March 27, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • analyze acute and late toxicities using CTCAE 4.03

    Patients will be followed for the duration of their life, an expected average of 20 years

  • analyze quality of life using LASA-3 and FACT-E

    Patients will be followed for the duration of their life, an expected average of 20 years

Secondary Outcomes (2)

  • analyze local control through tumor assessments

    Patients will be followed for the duration of their life, an expected average of 20 years

  • analyze survival by contacting patient and EMR (electronic medical record) review

    Patients will be followed for the duration of their life, an expected average of 20 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients being treated at Mayo Clinic with photon/ proton therapy.

You may qualify if:

  • Treated with photon/proton at Mayo Clinic Rochester in Radiation Oncology
  • Radiation therapy for curative intent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens stored for use in future research with permission of participant.

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Nadia N. Laack, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
100 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 29, 2015

Study Start

April 23, 2015

Primary Completion (Estimated)

April 30, 2031

Study Completion (Estimated)

April 30, 2031

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations