Cancer in Infants: South Egypt Cancer Institute Experience

Infantile Neoplasms Clinical Trial

Official title:

Cancer in Infants: South Egypt Cancer Institute Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02668354
• Other study ID #: Cancer in Infants SECI
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: April 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the spectrum of various types of malignant neoplasms of infancy, according to the experience of South Egypt Cancer Institute, which represents the largest referral site in Upper Egypt.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Infantile Neoplasms

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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
Primary	Event Free Survival (EFS)	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