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Follow-Up Study of People Treated for Scoliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02546479
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Social & Scientific Systems Inc.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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.


Condition or disease
Breast and Other Cancer Incidence and Mortality All Cause Mortality Circulatory Disease Mortality Respiratory Disease Mortality

Detailed 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.

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Study Type : Observational
Actual Enrollment : 5573 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast and Other Cancers Following X-Rays for Scoliosis
Study Start Date : September 9, 2015
Actual Primary Completion Date : August 16, 2016
Actual Study Completion Date : July 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort
Patientis
patients diagnosed with scoliosis and other spinal deformities



Primary Outcome Measures :
  1. Cancer incidence [ Time Frame: 1993 ]
    Incidence of breast and other cancers.

  2. Cancer and other disease mortality [ Time Frame: 2015 ]
    Mortality from cancer and other causes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • Data Analysis Only

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546479


Locations
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United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Social & Scientific Systems Inc.
Investigators
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Principal Investigator: Michele M Doody National Cancer Institute (NCI)
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02546479    
Other Study ID Numbers: 999915194
15-C-N194
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 11, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Mortality
Radiation
Spine deformities
Additional relevant MeSH terms:
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Scoliosis
Respiration Disorders
Respiratory Tract Diseases
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases