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Molecular Basis of Pediatric Liver Cancer

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ClinicalTrials.gov Identifier: NCT03959800
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Rakesh Sindhi, University of Pittsburgh

Tracking Information
First Submitted Date May 15, 2019
First Posted Date May 22, 2019
Last Update Posted Date September 10, 2019
Actual Study Start Date June 22, 2015
Estimated Primary Completion Date June 30, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2019)
  • Gene sequencing [ Time Frame: Recurrence free survival at 2 years ]
    DNA sequence variants
  • Gene expression analysis [ Time Frame: Recurrence free survival at 2 years ]
    Differentially expressed genes
  • Status of genome-wide chromatin accessibility [ Time Frame: Duration of active chemotherapy to two years after surgical treatment ]
    chromatin accessibility
  • Epigenetic change [ Time Frame: Duration of active chemotherapy to two years after surgical treatment ]
    Differential methylation
  • Tumor infiltrating cells which express immune checkpoints [ Time Frame: Duration of active chemotherapy to two years after surgical treatment ]
    differentially enriched immune cells
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03959800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 21, 2019)
  • Response to chemotherapy [ Time Frame: Duration of active chemotherapy to two years after surgical treatment ]
    Survival
  • Response to chemotherapy [ Time Frame: Duration of active chemotherapy to two years after surgical treatment ]
    Relapse
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Basis of Pediatric Liver Cancer
Official Title Genetic and Molecular Basis of Pediatric Liver Cancer
Brief Summary The purpose of this retrospective and prospective project is to understand the molecular and genetic basis of liver cancer of childhood. Understanding the molecular and genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.
Detailed Description

Pediatric liver cancers are rare, affecting at times no more than 1 in one million population. Understanding the molecular basis of these cancers is important in order to develop more accurate diagnoses and more effective treatments. Current classifications of these cancers are based on how these cancers look on diagnostic studies such as radiologic imaging or under the microscope. Such a classification system does not explain why a particular cancer has a different outcome from what is considered "usual" for that particular cancer. Nor does such a classification system explain why two different classes of cancers behave the same way. Understanding the genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.

To achieve these goals, large numbers of such cancer patients or affected tissue must be collected. This is not possible in any single institution, or any single country. The current project will collect biological samples such as residual tumor tissue, saliva, or blood from affected patients and their biological parents and families, along with clinical information about the cancer. These biological samples will be used to study the genes and how these genes work in tumor tissue and in non-tumor tissue. The results of this study will permit childhood liver cancers to be categorized on the basis of common defects in genes and their function.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Samples with DNA: blood, saliva or liver tissue.
Sampling Method Non-Probability Sample
Study Population Living or deceased individuals who were diagnosed with a liver tumor, malignant or benign, during childhood (age <21 years) and their biological parents and siblings.
Condition
  • Childhood Liver Cancer
  • Liver Malignant Tumors
  • Embryonal Sarcoma of Liver (Disorder)
  • Hepatoblastoma
  • Hepatocellular Carcinoma
  • Rhabdoid Tumor of Liver
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 21, 2019)
1600
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2029
Estimated Primary Completion Date June 30, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Prior or current treatment for a childhood liver tumor, malignant or benign, at age <21 years.
  • Biological parents and siblings of eligible children.

Exclusion Criteria:

  • No prior or current treatment for a childhood liver tumor.
  • Non-biological parents, legal guardians, or non-biological siblings of eligible children.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alexandra Kepler, MPH (412) 692-6692 alexandra.kepler@upmc.edu
Contact: Alexis Rzempoluch, MS (412) 692-5201 alexis.rzempoluch@chp.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959800
Other Study ID Numbers PRO14120080
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Rakesh Sindhi, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Pittsburgh
Verification Date September 2019