Childhood Cancer Survivor Study

Обзор

The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer and its associated therapies. A retrospective cohort study will be conducted through a multi-institutional collaboration, which will involve the identification and active follow-up of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age, between 1970 and 1999 and 10,000 sibling controls. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.

Подробное описание

The study will focus on the following objectives:

* Characterize survivors' health with respect to disease- and treatment-related factors. * Investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (e.g., cardiovascular, reproductive, second cancers, etc…). * Compare the mortality experience of survivors with the general population. * Characterize the health-related behaviors, patterns of medical care, and medical follow-up needs of survivors. * Describe patterns of familial aggregation of cancer, including known (and variations of) cancer family syndromes. * Collect and store biologic samples (saliva, blood, second tumor tissue) to correlate with health outcomes and use for future research.

Первичные конечные точки

• To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. [Срок оценки: 25 years]

Критерии участия

Критерии включения

Initial Cohort:

• Five-year survival following diagnosis of leukemia, lymphoma, CNS tumor, bone tumor, Wilms tumor, neuroblastoma, or soft tissue sarcoma before age 21 years between January 1, 1970 and December 31, 1986 at one of participating centers.

Expanded cohort:

• Five-year survival following diagnosis of leukemia, lymphoma, CNS tumor, bone tumor, kidney tumor, neuroblastoma, or rhabdomyosarcoma before age 21 years between January 1, 1987 and December 31, 1999 at one of participating centers.
• English- or Spanish-speaking and living in the U.S. or Canada at the time of diagnosis.

Критерии исключения

• Diagnosis of non-malignant tumors (i.e., Langerhans cell histiocytosis, meningioma, craniopharyngioma, etc.) treated with radiation and/or chemotherapy.
• Non-English speaking or residence outside the US or Canada.

Sibling Controls:

• For comparison purposes, a group of sibling controls will be identified to represent a stratified random sample based on the distribution of survivors with regard to cancer diagnosis, age, sex, race, and geographic location.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 30 центров

• University of Alabama at Birmingham/Children's of Alabama — Birmingham
• City of Hope National Medical Center — Duarte
• Children's Hospital Los Angeles — Los Angeles
• University of California-Los Angeles — Los Angeles
• Children's Hospital of Orange County — Orange
• University of California-San Francisco — San Francisco
• Stanford University School of Medicine — Stanford
• Children's Hospital Colorado — Aurora
• … и ещё 22 центра

Канада · 1 центр

• The Hospital for Sick Children — Toronto

Публикации

• Webster R, Chambers EO, Qiu W, Dhaduk R, Wang L, Yasui Y, Yuan Y, Nathan PC, Leisenring W, Armstrong GT, Howell R, Schulte T, Yalch M, Cordova M, Krull KR, Brinkman TM, Edelstein K. Neurocognitive impairment and substance use in adult survivors of childhood cancer: a cross-sectional analysis from the Childhood Cancer Survivor Study. EClinicalMedicine. 2026 Apr 29;95:103924. doi: 10.1016/j.eclinm.2 PMID 42094234
• Murphy AJ, Chen Y, Cameron DB, Geiger EJ, Ramsey D, Green DM, Howell RM, Kieran K, Krull KR, Meacham LR, Ness KK, Oeffinger KC, Yasui Y, Armstrong GT, Chow EJ, Weldon CB, Weil BR. Late complications of treatment for childhood pelvic sarcoma: A report from the Childhood Cancer Survivor Study (CCSS). J Pediatr Surg. 2026 Jul;61(7):163117. doi: 10.1016/j.jpedsurg.2026.163117. Epub 2026 Mar 30. PMID 41921603
• Bashore L, Peterson RK, Li C, Liu W, Wang M, Jiwani ZM, McDonald AJ, Lupo PJ, King A, Srivastava D, Leisenring WM, Howell RM, Gibson TM, Oeffinger K, Armstrong GT, Bowman WP, Krull KR, Edelstein K. Chronic Health Conditions and Academic Achievement: A Childhood Cancer Survivor Study Report. JCO Oncol Pract. 2026 Jul;22(7):1322-1330. doi: 10.1200/OP-25-00414. Epub 2025 Sep 8. PMID 40920992
• Alberts NM, Leisenring W, Whitton J, Stratton K, Jibb L, Flynn J, Pizzo A, Brinkman TM, Birnie K, Gibson TM, McDonald A, Ford J, Olgin JE, Nathan PC, Stinson JN, Armstrong GT. Characterization of chronic pain, pain interference, and daily pain experiences in adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Pain. 2024 Nov 1;165(11):2530-2543. doi: 10.1097/j.pa PMID 38981063
• Wilson CL, Bjornard KL, Partin RE, Kadan-Lottick NS, Nathan PC, Oeffinger KC, Hayashi RJ, Hyun G, Armstrong GT, Leisenring WM, Howell RM, Yasui Y, Dixon SB, Ehrhardt MJ, Robison LL, Ness KK. Trends in physical functioning in acute lymphoblastic leukemia and non-Hodgkin lymphoma survivors across three decades. J Cancer Surviv. 2025 Apr;19(2):496-506. doi: 10.1007/s11764-023-01483-1. Epub 2023 Nov 8 PMID 37938431
• Chen C, Qin N, Wang M, Dong Q, Tithi SS, Hui Y, Chen W, Wu G, Kennetz D, Edmonson MN, Rusch MC, Thrasher A, Easton J, Mulder HL, Song N, Plonski NM, Shelton K, Im C, Ehrhardt MJ, Nichols KE, Leisenring WM, Stratton KL, Howell R, Yasui Y, Bhatia S, Armstrong GT, Ness KK, Hudson MM, Zhang J, Wang H, Srivastava DK, Robison LL, Wang Z. Cancer germline predisposing variants and late mortality from subs PMID 37797633
• Mulrooney DA, Hyun G, Ness KK, Ehrhardt MJ, Yasui Y, Duprez D, Howell RM, Leisenring WM, Constine LS, Tonorezos E, Gibson TM, Robison LL, Oeffinger KC, Hudson MM, Armstrong GT. Major cardiac events for adult survivors of childhood cancer diagnosed between 1970 and 1999: report from the Childhood Cancer Survivor Study cohort. BMJ. 2020 Jan 15;368:l6794. doi: 10.1136/bmj.l6794. PMID 31941657
• Ness KK, Hudson MM, Jones KE, Leisenring W, Yasui Y, Chen Y, Stovall M, Gibson TM, Green DM, Neglia JP, Henderson TO, Casillas J, Ford JS, Effinger KE, Krull KR, Armstrong GT, Robison LL, Oeffinger KC, Nathan PC. Effect of Temporal Changes in Therapeutic Exposure on Self-reported Health Status in Childhood Cancer Survivors. Ann Intern Med. 2017 Jan 17;166(2):89-98. doi: 10.7326/M16-0742. Epub 2016 PMID 27820947

Идентификаторы

NCT: NCT01120353 · CCSS · U24CA055727 · R03CA169150 · R01CA134722 · R01CA136783 · R01CA132899 · R01CA187397 · R01CA175231 · R21CA202210 · R21CA198641 · NCI-2021-05717

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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