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Mechanisms and Predictors of Unusual Radiation or Chemotherapy Toxicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469194
Recruitment Status : Withdrawn
First Posted : June 11, 2015
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:

In general, the toxicity of radiation therapy and chemotherapy exhibits a strong dose-response relationship. However, patients receiving similar doses still exhibit a range of toxicity responses due to a variety of factors, including comorbid conditions, disease (cancer) specific factors, and inter-individual genetic variation. A very small percentage of patients experience side effects that are either extremely severe or extremely mild compared to the majority of patients for the dose of radiation or chemotherapy given. Currently, the reasons for this are not entirely clear, but likely relate to patient specific factors such as immune response, cell/tissue repair capacity and other factors that fundamentally rely on rare genetic variations at loci involved in these responses. For example, patients with homozygous deletions in DNA damage response genes such as ATM are uniquely sensitive to DNA damaging agents. Many patients with severe, homozygous mutations in such genes have other sequela that lead to medical recognition of the syndrome prior to therapy. The investigators hypothesize that patients with unusually severe toxicity from therapy that do not exhibit classical signs of homozygous mutation syndromes are heterozygous for nonfunctional or hypofunctional alleles at these loci, such that the defect is only uncovered under the relatively acute, severe stress on that pathway by radiation or chemotherapy. Conversely, patients with very mild reactions could exhibit rare variants/combinations of variants that make them uniquely resistant to chemotherapy or radiotherapy toxicity.

The purpose of the study is to better understand these mechanisms with the eventual goal of developing predictive markers that will allow us to help individually tailor cancer therapy is in future patients. Will accomplish these goals by studying a variety of factors from a single vial of blood. These will include circulating proteins and hormones, circulating cells and the levels and sequences of white blood cell DNA or RNA using a variety of techniques including but not limited to determination of cytokine/hormone levels, proteomic analysis, immunocytochemical assays, whole exome sequencing and qPCR.


Condition or disease Intervention/treatment
Severe or Mild Toxicity From Radiotherapy and/or Chemotherapy Other: Blood Draw

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms and Predictors of Unusual Radiation or Chemotherapy Toxicity
Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Intervention Details:
  • Other: Blood Draw
    5-10 cc of whole blood will be obtained using standard, sterile venipuncture techniques


Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
5-10 cc of whole blood will be obtained using standard, sterile venipuncture techniques


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be recruited from the inpatient and outpatient clinical practices in the University of Pennsylvania Health System. There will be no attempt to advertise enrollment on this protocol to physicians outside of the treating departments (i.e. Radiation Oncology, Surgery, Medical Oncology).
Criteria

Inclusion Criteria:

  • Subjects will be age 18 or greater Subjects will have undergone chemotherapy and/or radiotherapy and experienced unusually mild or severe toxicity.

Exclusion Criteria:

  • Subjects for who, after initial review of medical records by study team personnel are not judged by the PI and/or sub-investigators to have sufficiently unusual toxicity from therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469194


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Keith Cengel, MD, PhD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02469194    
Other Study ID Numbers: UPCC 09915
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019