Follow-Up Study of People Treated for Scoliosis

NCT02546479 | Completed

• 2 other identifiers: 99991519415-C-N194
• Study Type: observational
• Target: 5,573
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast and Other Cancer Incidence and Mortality; All Cause Mortality; Circulatory Disease Mortality; Respiratory Disease Mortality

Keywords

Mortality; Radiation; Spine deformities

Outcome Measures

Primary Outcomes (2)

• Cancer incidence

  Incidence of breast and other cancers.

  1993

• Cancer and other disease mortality

  Mortality from cancer and other causes.

  2015

Study Arms (1)

Patientis

patients diagnosed with scoliosis and other spinal deformities

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Data Analysis Only

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Social & Scientific Systems Inc.: collaborator

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related 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. doi: 10.1097/00007632-200008150-00009.

  PMID: 10954636 BACKGROUND

• 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.

  PMID: 18349278 BACKGROUND

• 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.

  PMID: 20681802 BACKGROUND

Study Officials

• Michele M Doody

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: September 9, 2015
• Primary Completion: August 16, 2016
• Study Completion: July 11, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07-11

Locations

US (1)