Data Collection, Clinical Care and Interventions in CCR, NCI
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- establishment of data repository for standard of care participants
研究概览
简要总结
This study provides cancer care through the National Cancer Institute's Medical Oncology Branch (MOB) to patients who are not enrolled in an active treatment research protocol. Patients receive standard treatments only; no investigational therapies are provided on this protocol.
Patients 18 years of age and older may be eligible for this protocol. Candidates are patients for whom an NCI investigator decides that the interests of the patient and the NCI are best served by the patient's enrollment in this protocol to receive care and follow-up within the MOB. This includes patients in the following categories:
- Patients previously enrolled in NCI trials whose participation in this protocol may continue to provide researchers important scientific information
- Patients who will be eligible for a research protocol within the foreseeable future
- Patients whose medical welfare will be seriously compromised by referral back to the community, such as patients with a rare or complex disease for which community resources are inadequate or unavailable
- Terminally ill patients who have received most of their specialized medical care at the Clinical Center and for whom humanitarian considerations dictate that they continue to receive their medical care at NIH after going off study for the remaining weeks or months of life
- Patients with cancer or HIV, or people at risk for cancer or HIV for whom cancer treatments at the NCI are requested through the MOB consult service
- Patients who are participating in a non-treatment NCI research protocol and require standard-of-care therapy
- Patients with cancer or HIV or people at risk for cancer for whom cancer treatment or management at the NCI would add significant value to the institute's cancer training program
Participants receive standard medical care, including periodic routine laboratory tests, diagnostic x-rays, and nuclear medicine scans to monitor the course of illness and the effects of any treatment.
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详细描述
Background:
- Clinical Investigators within the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) evaluate and treat patients with cancer, HIV, and individuals at risk for developing cancer in the context of active research protocols.
- In some cases, it may be in the best interests of both the individual and the CCR to provide consult services, treatment/interventions, and/or follow-up to certain individuals and collect the data obtained for future research.
Objectives:
-To provide a repository of information on enrolled participants to allow for hypothesis generation in future research
Eligibility:
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
- 4 Weeks 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Individuals must be age 2 years or older if therapeutic interventions are required. Otherwise, there are no age restrictions beyond the neonatal period (4 weeks).
- •Individuals will be eligible if they meet one of the following criteria:
- •are seeking a consultation from NCI/CCR.
- •whose medical welfare will be seriously compromised by referral back to the community, such as rare/complex diseases in which community treatment is inadequate or adequate community resources are unavailable.
- •have cancer, HIV, or are at risk for cancer and/or HIV for whom cancer evaluation, treatment or management at the NCI is requested.
- •who will serve or have served as cellular therapy donors, for the treatment of a recipient of cellular therapy on an NCI trial.
- •are participants or biologic family members of deceased participants, where genetic testing is required or a clinically actionable germline pathogenic or likely pathogenic variant with medical implications was discovered by a research laboratory that requires CLIA confirmation. Note: In some cases, enrollment onto this study is also necessary when the prior study on which the involved participant was originally enrolled is closed and/or the participant is now off study.
- •The individual or their Legally Authorized Representative is able and willing to provide informed consent.
排除标准
- 未提供
研究组 & 干预措施
Consults
Individuals being seen as a consult.
Genetic Follow-Up
Individuals with a known/suspected germline genomic research incidental pathogenic or likely pathogenic variant, and/or who require CLIA confirmation.
Patients
Individuals being enrolled for the treatment or follow-up of their disease.
Donors
Donors of cellular products.
结局指标
主要结局
establishment of data repository for standard of care participants
时间窗: ongoing
Obtain and store information from participants seen for consult, treatment and medical follow-up for NCI patients, other Institute patients and individuals as specified.
次要结局
未报告次要终点