A Registry of Patient Data and DNA Samples for Early Detection of Radiation Related Side Effects

Overview

About this study

The purpose of this study is to help predict which patients are at greater risk for side effects from radiotherapy.

Aims, purpose, or objectives:

  1. Establish a prospective cohort of 500 patients with breast, lung, and prostate cancer treated with external beam radiotherapy at Mayo Clinic Florida followed with standardized quality of life and toxicity assessments.
  2. Establish a registry of patient data and germline DNA samples for validation of models and biomarkers for early detection of risk of radiotherapy related side effects.
  3. The registry will establish a cohort of patients at May Clinic Florida that can be used as a resource for external partnerships in research.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

• Confirmed diagnosis of the specified tumour types, for lung cancer confirmation either by histology or based on radiological findings

• Patients suitable for adjuvant radiotherapy for cancer of the breast (invasive or in situ) including breast patients receiving neo-adjuvant chemotherapy (Patients receiving chemotherapy should have completed their course of chemotherapy (anthracyclines) at least two weeks prior to radiotherapy commencing.

• Patients suitable for radical radiotherapy or brachytherapy for prostate cancer; including post-prostatectomy patients

• Patients suitable for radical radiotherapy, sequential or concurrent chemoradiotherapy or stereotactic body radiation therapy (SBRT) for lung cancer

• No other malignancy in the last 5 years prior to treatment for the specified tumour types except basal cell or squamous cell carcinoma of the skin

• No evidence of distant metastases

• Patients able to provide a venous blood sample

• Breast patients consent to have photos taken of both breasts

• Willingness and ability to comply with scheduled visits, treatment plans and available for follow up

• Greater than 18 years of age; no upper age limit

• The capacity to understand the patient information sheet and the ability to provide written informed consent

 

Exclusion Criteria

• Patients with metastatic disease

• Prior irradiation at the same site

• Planned use of protons

• High Intensity Focal Ultrasound (HIFU)

• Breast patients receiving concomitant chemo-radiation

• Male breast cancer patients

• Mastectomy patients

• Bilateral breast cancer

• Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires

• Limited life expectancy due to co-morbidity

• Pregnant patients

• Partial breast irradiation

• Patients with breast implants if not removed during surgery

• Patients with known HIV infection/infectious hepatitis

 

Describe provisions for inclusion of minorities:  The study will be open to all patients treated with radiotherapy at Mayo Clinic Florida.

 

Provide the proposed number of subjects to be included in the repository: 500

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Robert Miller, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions