- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02668354
Cancer in Infants: South Egypt Cancer Institute Experience
Study Overview
Status
Conditions
Detailed Description
Background:
Cancer in the first year of life is relatively rare ; however, the age of peak cancer incidence among children occurs during the first year of life, representing 10% of all cancer that was diagnosed among children younger than 15 years of age. Female and male infants have essentially the same overall cancer incidence rates.
Cancer occurring in infants often has a clinical and biological behavior that is different from cancers occurring in older children. The histologic distribution of cancers in infants and that in older children are also different.
Patients & Methods:
From January 2001 to December 2015, retrieval & analysis of the medical records of infant patients, diagnosed with any of malignant tumors, at the pediatric oncology department at South Egypt Cancer Institute will be done. Pathologic diagnoses & age of the patients will be verified for the enrollment in the study. The collected data will be analyzed to delineate the spectrum of these disease entities, their clinico-pathologic features, associated patients' demographics and characteristics, treatment modalities received, and outcomes of these treatments.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Assiut, Egypt, 71515
- Recruiting
- Assiut University
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Contact:
- Ahmed M. Morsy, MD
- Phone Number: +2 01003314522
- Email: ahmedmohammed7829@yahoo.com
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Principal Investigator:
- Ahmed M. Morsy, MD
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Principal Investigator:
- Ameer M. Abuelgheet, MD
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Principal Investigator:
- Omnia N. AbdelHamid, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients whose age less than or equal to 1 year.
- Patients diagnosed with any of malignant neoplasms.
Exclusion Criteria:
• Patients whose age more than 1 year.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
|
Time from the date of initiation of treatment until death from any cause
|
Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
|
Event Free Survival (EFS)
Time Frame: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
|
Time from the date of initiation of treatment until disease progression, or death for any reason
|
Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chen, S.-H., Y.-L. Liu, et al. (2014). Infants with cancer: A unique population. Journal of Experimental & Clinical Medicine 6(1): 1-9.
- Dreyer, Z., D. Indelicato, et al. (2011). Infants and adolescents with cancer: special considerations. In: Pizzo PA, Polackand DG, editors. Principles and practice of pediatric oncology. 6th ed. Riverwoods, IL: Lippincott Williams & Wilkins.
- Gurney, J. G., M. A. Smith, et al. (1999). Cancer among infants. Cancer incidence and survival among children and adolescents: United States SEER Program 1975-1995: 149-156.
- Yang CP, Hung IJ, Jaing TH, Shih LY, Chang WH. Cancer in infants: a review of 82 cases. Pediatr Hematol Oncol. 2005 Sep;22(6):463-81. doi: 10.1080/08880010591002233.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Cancer in Infants SECI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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