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Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy

National Cancer Institute (NCI) logo

National Cancer Institute (NCI)

Status

Enrolling

Conditions

Cancer

Study type

Observational

Funder types

NIH

Identifiers

NCT00026650
00-C-0074
000074

Details and patient eligibility

About

BACKGROUND

  • This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols.
  • It also provides a mechanism for the correlation and interpretation of disparate data for research into the long term side effects and outcomes for a variety of disease entities and treatments, such as combined modality treatment, MoAb, PDT, radiation modifiers,

intraoperative radiotherapy, etc.

OBJECTIVE

-The primary objective of this protocol is to assess the late effects of treatment and the natural history of disease through collection of data from any standard procedures performed as part of follow up care on participants previously treated with radiotherapy.

ELIGIBILITY

-Participants who received radiation therapy.

DESIGN

  • This is a natural history protocol in which long-term follow up data will be collected from participants who received radiation therapy.
  • It will be made clear to participants in the consent form, that data collected during their follow-up may be used anonymously for publications concerning the natural history of disease processes and long-term effects of treatment.

Full description

BACKGROUND

  • This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols.
  • It also provides a mechanism for the correlation and interpretation of disparate data for research into the long term side effects and outcomes for a variety of disease entities and treatments, such as combined modality treatment, MoAb, PDT, radiation modifiers,

intraoperative radiotherapy, etc.

OBJECTIVE

-The primary objective of this protocol is to assess the late effects of treatment and the natural history of disease through collection of data from any standard procedures performed as part of follow up care on participants previously treated with radiotherapy.

ELIGIBILITY

-Participants who received radiation therapy.

DESIGN

  • This is a natural history protocol in which long-term follow up data will be collected from participants who received radiation therapy.
  • It will be made clear to participants in the consent form, that data collected during their follow-up may be used anonymously for publications concerning the natural history of disease processes and long-term effects of treatment.

Enrollment

700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • INCLUSION CRITERIA:

ROB investigator deems that it is in the best interests of the participant and the NCI/ROB for the participant to be seen in follow-up in the ROB clinic.

Participant is able to provide informed consent.

Participant must have a primary physician in the community to whom records and appropriate follow-up management can be given. Social services will be enlisted for any participants who lack health insurance, etc.

Participants who have received radiotherapy.

Age greater than or equal to 18 years of age

EXCLUSION CRITERIA:

Participants who are on an interventional research protocol at NIH at the time of enrollment.

Trial design

700 participants in 1 patient group

1/Cohort 1
Description:
Patients who have received radiotherapy in the ROB and may or may not be officially entered on a clinical protocol.

Trial contacts and locations

1

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Central trial contact

Kevin A Camphausen, M.D.; Theresa C Cooley Zgela, R.N.

Data sourced from clinicaltrials.gov

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