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Идёт набор NCT00992303

Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants

— Наблюдательное Unspecified Adult Solid Tumor, Protocol Specific

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: biologic sample preservation procedure, medical chart review, questionnaire administration.
Кому может быть актуально
Состояния в реестре: Unspecified Adult Solid Tumor, Protocol Specific. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients and Healthy Participants

Обзор

RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the laboratory may help the study of cancer in the future. PURPOSE: This research study is collecting tissue samples from patients with cancer undergoing radiation therapy. Healthy participants will also be allowed on the trial so their samples can be used in comparison to patients with malignancy

Подробное описание

OBJECTIVES:

Primary

* To maintain and create a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database that will be used to explore genetic variations contributing to clinical outcomes through tissue analysis and outcome correlation. Tissue will be stored by the UTSTR and the database managed by Radiation Oncology.

Secondary

* To document disease outcome (local recurrence, distant metastasis, overall survival) by treatment regimen and disease site. * To document toxicity by treatment regimen and disease site. * To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.

OUTLINE: Tissue, including surgical waste, venous blood/serum, urine, bone marrow, and other body fluids, may be collected (at planned surgery and routine medical visits) and preserved for future research. Demographic and disease and treatment information is obtained from patients (by interview or questionnaire), from medical records, and from national datasets. Patients may also be asked to provide additional blood samples and/or a small skin-punch biopsy sample.

Patients are followed up every 6 months for the first two years following treatment and then yearly thereafter.

Вмешательства

  • Другое biologic sample preservation procedure
  • Другое medical chart review
  • Другое questionnaire administration

Первичные конечные точки

  • Maintenance a Tissue Resource and Registry/Database [Срок оценки: 10 years]
Вторичные конечные точки (5)
  • Local recurrence [Срок оценки: 5 years]
  • Distant metastasis [Срок оценки: 5 years]
  • Overall survival [Срок оценки: 5 years]
  • Toxicity by treatment regimen [Срок оценки: 1 year]
  • Establishment of a prospective registry/database [Срок оценки: 10 years]

Критерии участия

DISEASE CHARACTERISTICS:

  • Pathologically-proven diagnosis of malignancy
  • Planning treatment with radiation therapy

PATIENT CHARACTERISTICS:

  • Able to perform follow-up visits
  • Is a patient of the University of Texas Southwestern Medical Center physicians

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Participation in other clinical trials is allowed
  • Other prior or concurrent therapy for cancer, such as surgery and/or chemotherapy, is allowed.

Criteria for eligibility:

  • Able to provide written informed consent
  • Age greater than 18 years old
  • Males and Females are eligible
  • Any ethnicity is eligible

Criteria for ineligibility:

-Patients not available for follow-up/future contact

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 1 центр
  • UT Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT00992303 · STU 072010-098 · SCCC-032009-049 · CDR0000653406

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗