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Evaluation of Late Treatment Effects in Long-Term Survivors of Hodgkin's Disease Previously Treated at NIH: A Multi-Institutional Trial

2017년 6월 30일 업데이트: National Cancer Institute (NCI)

Background:

  • Researchers are greatly interested in knowing more about the long-term effects of various treatments for cancers such as Hodgkin's disease, particularly from those who have lived 20 to 30 years after treatment.
  • Patients who were treated at the National Institutes of Health (NIH) may have undergone different treatments for which more long-term information is needed.

Objectives:

  • To examine the body systems of long-term survivors of Hodgkin's disease to see if there are any long- term consequences of treatment for Hodgkin's disease.
  • To learn more about the long-term effects of cancer treatments.

Eligibility:

  • Survivors of Hodgkin's disease who were previously treated at the NIH.
  • Participants must be at least 18 years of age.

Design:

  • Participants will need to sign consent forms to allow researchers to obtain documentation of medical history, including prior treatment for Hodgkin's disease and prior NIH treatment, including protocol number, where applicable:
  • Pertinent medical records, pathology reports, and radiographic imaging studies will be reviewed.
  • Primary care physician's name, address, and other contact information are also required.
  • Evaluations during the assessment period:
  • Complete physical examination.
  • Laboratory studies of blood, urine, and stool samples.
  • Radiologic evaluations, including computerized tomography (CT) and magnetic resonance imaging (MRI) scans for all participants and mammograms for females.
  • Cardiac evaluation, vascular studies, and pulmonary studies to measure heart and lung function, and digestive tests to measure stomach and intestinal function.
  • Neurocognitive testing to measure brain function.
  • Optional skin biopsy.
  • Participants will be asked to complete questionnaires assessing current quality of life and daily living skills.

연구 개요

상태

완전한

상세 설명

BACKGROUND:

Nearly 75% of Hodgkin's Disease (HD) patients can be cured of their disease with chemotherapy and radiotherapy, resulting in a growing number of long-term survivors.

Adverse effects of HD treatments, including second malignancies and cardiovascular disease, affect survival and quality of life. Minimizing late toxicities has become a major emphasis of current and investigational regimens.

Better characterization of long-term toxicity and quality of life (QOL) after therapy for HD and the ability to determine which late toxicities arise from a given modality may allow an ability to shape future regimens such that late toxicity can be minimized.

OBJECTIVES:

Primary objectives:

To describe the cardiac, pulmonary, and vascular function in patients previously treated for HD at NIH and to correlate this information to the treatment received.

  • To measure cardiac function and abnormalities and to correlate these findings with treatment received.
  • To measure pulmonary function with pulmonary function testing in survivors of HD and to correlate these findings with treatment received.
  • To measure vascular function in survivors of HD and to correlate these findings with treatment received.

Secondary Objectives:

To determine if elevated plasma TGF levels correlate with the presence of late radiation fibrosis in long-term survivors of HD.

To evaluate late quality of life (QOL) in long-term survivors of HD and to correlate QOL with treatment received.

To evaluate and describe additional exploratory measures of organ function in patients previously treated for HD at NIH and to correlate this information to the treatment received.

  • Heart rate variability
  • Pulmonary fibrosis.
  • Intestinal function.
  • Neurocognitive function.

To evaluate the correlation of exploratory functional assays, biomarkers, and single nucleotide polymorphisms with the presence of late chemotherapy or radiation toxicity in long-term HD survivors.

ELIGIBILITY:

Survivors of HD previously treated at the NIH.

DESIGN:

This is a single point in time follow-up evaluation of long-term HD survivors, previously treated at the NIH.

Patients will be evaluated for late toxicities in multiple organ systems using imaging modalities, laboratory tests, functional assays, and investigational studies.

연구 유형

관찰

등록 (예상)

157

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Maryland
      • Bethesda, Maryland, 미국, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

  • INCLUSION CRITERIA:

Inclusion Criteria for all Participants:

  • Patients must be at least 18 years of age 15
  • Patients must have been previously treated for Hodgkin's Disease at the NIH
  • Patient must be willing to complete quality of life questionnaires and to answer questions regarding their medical history
  • Patient must be willing to provide release of medical information forms for physicians and hospitals involved in their management

Inclusion Criteria for Evaluation at NIH/NIA:

In addition to those above,

  • Patient is willing to return to NIH/NIA to participate in the protocol
  • Patient must have a primary physician in the community who is willing to communicate with NIH regarding clinical findings and collaborate in the clinical management and follow-up of the patient. This will be substantiated by communicating directly with the patient's physician prior to evaluation.
  • Pregnant patients are eligible for follow up evaluations and quality of life evaluations. They will be excluded for any radiological testing and invasive studies. Any blood draws will be approved by the patient's obstetrician and if any of the laboratory tests to be performed have been carried out within the last three months, those values will be used instead of repeating them. Alternatively, pregnant patients may choose to participate in the study after the birth of their child to be able to participate in the full evaluation.

EXCLUSION CRITERIA:

  • Inability to give informed consent
  • Patients, and/ or guardians who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol evaluations and follow-up requirements.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 4월 17일

연구 완료

2010년 5월 26일

연구 등록 날짜

최초 제출

2009년 6월 17일

QC 기준을 충족하는 최초 제출

2009년 6월 17일

처음 게시됨 (추정)

2009년 6월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 7월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 6월 30일

마지막으로 확인됨

2010년 5월 26일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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