Follow-Up Study of People Treated for Scoliosis

All Cause Mortality Clinical Trial

Official title:

Breast and Other Cancers Following X-Rays for Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546479
• Other study ID #: 999915194
• Secondary ID: 15-C-N194
• Status: Completed
• Start date: September 9, 2015
• Est. completion date: July 11, 2019

Study information

• Verified date: July 11, 2019
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

Scoliosis is a curving of the spine. It usually happens in girls when they are children and teens. Doctors often use x-rays to diagnose it. The x-rays give low radiation. This may increase the risk that those young women get cancer later in life. Researchers want to learn more about this risk. They will look data that has already been collected.

Objectives:

To study cancer risks of repeated low radiation from x-rays for scoliosis. Also, to study death risks related to certain scoliosis patient characteristics. These include causes, kinds of curvature, and kinds of treatment.

Eligibility:

Medical records of women from past scoliosis studies.

Design:

This U.S. Scoliosis Cohort includes more than 5,000 women who were diagnosed between 1912 and 1965.

Data were collected on these women in the 1980s and 1990s. These came from medical records, radiology log books, and x-ray films. Researchers found out where participants were, including if they were dead. Some women were given a follow-up questionnaire.

Researchers want to find out where participants are today. They want to identify new deaths of participants. They want to find out their causes of death. This data will be added to other databases.

Description:

U.S. Scoliosis Cohort includes 5,573 female spinal deformity (93% scoliosis) patients diagnosed in any of 14 medical centers in the U.S. during 1912-1965. The primary objective of this study is to evaluate site-specific cancer risks associated with repeated low-dose radiation exposures from diagnostic x-rays. A secondary objective is to evaluate late mortality risks associated with patient characteristics, such as etiology, degree and type of curvature, and type of treatment. The current proposal is to extend mortality follow-up by 10 years. All patients not known to be deceased will be submitted to the National Death Index Plus to identify new deaths and obtain causes of death.

A feasibility study was conducted in four medical centers in the Minneapolis-St. Paul, Minnesota area during 1983-1987. The primary goals of the feasibility study were to ascertain if an adequate number of patients meeting the study criteria could be identified and located, medical and radiography records were available and substantially complete, organspecific radiation doses could be estimated from the available data and were large enough to warrant further study, and a reasonable percentage of patients would complete a follow-up questionnaire. The feasibility study was successful in meeting all goals. Enrolled for study were 1,030 female patients with spinal deformities diagnosed during 1922-1965. Medical records were abstracted, individual x-ray films were reviewed, patients were located, and follow-up questionnaire was administered to identify incident cancers. Eleven breast cancers were reported. Scoliosis patients had an 80% higher breast cancer risk compared to women in the general population and, based on internal cohort analyses, breast cancer risk increased with increasing number of x-rays and with estimated radiation dose to the breast.

An expanded study was conducted during 1988-1993. The main goals of the expanded study were to enlist the collaboration of suitable additional medical centers where large numbers of spinal deformity patients were treated before 1966, abstract data from medical and radiology records, trace patients for vital status and current location, obtain information on incident cancers and cancer risk factors by questionnaire, medically validate reported cancers, and determine causes of death for decedents. Another 4,543 patients diagnosed during 1912-1965 were enrolled from ten hospitals, bringing the total study population to 5,573 patients. Compared to women in the general population, spinal deformity patients had statistically significantly higher risks of dying from breast cancer, and for both incidence and mortality, breast cancer risk increased with increasing diagnostic radiation exposure to the breast. Patients also have elevated risks for mortality from all causes, circulatory, respiratory, nervous system, musculoskeletal, digestive, and infectious & parasitic diseases, primarily related to degree of spinal curvature. Additional mortality follow-up will enable more definitive assessments of cancer and other disease risks with radiation and other factors in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5573
• Est. completion date: July 11, 2019
• Est. primary completion date: August 16, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 95 Years
• Eligibility: - Data Analysis Only

Related Conditions & MeSH terms

• All Cause Mortality
• Breast and Other Cancer Incidence and Mortality
• Circulatory Disease Mortality
• Respiration Disorders
• Respiratory Disease Mortality
• Respiratory Tract Diseases
• Scoliosis

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI), 9000 Rockville Pike	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Social & Scientific Systems Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Doody MM, Lonstein JE, Stovall M, Hacker DG, Luckyanov N, Land CE. Breast cancer mortality after diagnostic radiography: findings from the U.S. Scoliosis Cohort Study. Spine (Phila Pa 1976). 2000 Aug 15;25(16):2052-63. — View Citation

Ronckers CM, Doody MM, Lonstein JE, Stovall M, Land CE. Multiple diagnostic X-rays for spine deformities and risk of breast cancer. Cancer Epidemiol Biomarkers Prev. 2008 Mar;17(3):605-13. doi: 10.1158/1055-9965.EPI-07-2628. — View Citation

Ronckers CM, Land CE, Miller JS, Stovall M, Lonstein JE, Doody MM. Cancer mortality among women frequently exposed to radiographic examinations for spinal disorders. Radiat Res. 2010 Jul;174(1):83-90. doi: 10.1667/RR2022.1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer incidence	Incidence of breast and other cancers.	1993
Primary	Cancer and other disease mortality	Mortality from cancer and other causes.	2015