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临床试验/NCT02546479
NCT02546479已完成不适用

Breast and Other Cancers Following X-Rays for Scoliosis

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 5,573 人开始时间: 2015年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,573
试验地点
1
主要终点
Cancer incidence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 95 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cancer incidence

时间窗: 1993

Incidence of breast and other cancers.

Cancer and other disease mortality

时间窗: 2015

Mortality from cancer and other causes.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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