Infantile NeoplasmsNCT02668354
Cancer in Infants: South Egypt Cancer Institute Experience
An observational study of Infantile Neoplasms, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Infantile Neoplasms
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2017to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Infants, those diagnosed with any of malignant neoplasms, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.
Who may be able to join
- Patients whose age less than or equal to 1 year.
- Patients diagnosed with any of malignant neoplasms.
Who cannot join
- Patients whose age more than 1 year.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Ahmed M. Morsy, MD, +2 01003314522, ahmedmohammed7829@yahoo.com
Ahmed M. Morsy, MD
About this study
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.
Read the 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.
- Conditions
- Infantile Neoplasms
- Keywords
- Childhood Cancer, Pediatric Oncology, Infant tumors
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time from the date of initiation of treatment until death from any cause
Measured: 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 from the date of initiation of treatment until disease progression, or death for any reason
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start1 Feb 2017
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infantile NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Morsy, MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668354
- Sponsor's protocol ID
- Cancer in Infants SECI
- Status last verified
- Jul 2023
- First submitted
- 27 Jan 2016
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16169813
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer in Infants: South Egypt Cancer Institute Experience
- ClinicalTrials.gov ID
- NCT02668354
- Acronym / sponsor ID
- Cancer in Infants SECI
- Conditions
- Infantile Neoplasms
- Keywords
- Childhood Cancer, Pediatric Oncology, Infant tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants, those diagnosed with any of malignant neoplasms, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.
Key inclusion criteria (2 listed)
- Patients whose age less than or equal to 1 year.
- Patients diagnosed with any of malignant neoplasms.
Key exclusion criteria (1 listed)
- Patients whose age more than 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- BackgroundChen, S.-H., Y.-L. Liu, et al. (2014). Infants with cancer: A unique population. Journal of Experimental & Clinical Medicine 6(1): 1-9.
- BackgroundDreyer, 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.
- BackgroundGurney, 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.
- Background: PubMed 16169813Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infantile Neoplasms, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02668354, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.