Head and Neck NeoplasmsNCT02557048
Head and Neck Cancer in Children: A Retrospective Study
An observational study of Head and Neck Neoplasms and Cancer of Head and Neck, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of the study is to identify demographic characteristics, various histopathologies, and site preferences for each disease entity of malignant head and neck tumors in pediatric oncology patients \& treatment outcomes in these patients, according to experience at South Egypt Cancer Institute which is the largest… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Head and Neck Neoplasms, Cancer of Head and Neck, Cancer of the Head and Neck
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2019to Dec 2023
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A hospital-based study, involving Pediatric cancer patients, those diagnosed with malignant tumors of the head \& neck, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical reports will be retrospectively reviewed for data collection.
Who may be able to join
- Patients whose age less than 19 years.
- Patients diagnosed with a primary malignant tumor of the head \& neck.
Who cannot join
- Patients whose age more than 18 years.
- Patients diagnosed with a malignant disease primarily arising from the bone marrow.
- Patients diagnosed with tumors of the central nervous system.
- Patients diagnosed with retinoblastoma.
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
Official title: Malignant Head and Neck Tumors in Children: A Retrospective Study
The aim of the study is to identify demographic characteristics, various histopathologies, and site preferences for each disease entity of malignant head and neck tumors in pediatric oncology patients \& treatment outcomes in these patients, according to experience at South Egypt Cancer Institute which is the largest referral site in Upper Egypt.
Read the detailed description
Background:
Although head and neck masses represent a common entity in children, malignancy is uncommon. Only very limited data are available in the literature on the incidence of childhood cancer of the head and neck worldwide.
Data from the United States National Cancer Institute database suggest that the head and neck are involved in 12 % of all childhood malignancies. The most common pediatric head and neck malignancies include Non Hodgkin lymphomas, Hodgkin lymphomas, rhabdomyosarcomas, thyroid malignancies, nasopharyngeal carcinomas (NPCs), salivary gland malignancies, and neuroblastomas.
Patients \& Methods:
A hospital-based study, involving Pediatric cancer patients, those diagnosed with malignant tumors of the head \& neck, 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.
Clinico-laboratory data for each hisopathologic disease entity of various head \& neck malignancies will be gathered. The demographic distribution for each disease entity in accordance with gender \& age, and site preferences in these disease entities will be recorded. Treatment received \& treatment outcomes will be verified and absolute frequencies \& relative incidence of these disease entities will be calculated.
- Conditions
- Head and Neck Neoplasms, Cancer of Head and Neck, Cancer of the Head and Neck, Head and Neck Cancer, Neoplasms, Head and Neck
- Keywords
- Childhood Cancer, Head and Neck Tumors, Pediatric Oncology
- Medical subject headings
- Head and Neck Neoplasms, 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 posted22 Sep 2015 (estimated)
- Study start10 Jan 2019
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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
- 120 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
- NCT02557048
- Sponsor's protocol ID
- Ped Head Neck Malig
- Status last verified
- Jul 2023
- First submitted
- 21 Sep 2015
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Chadha NK, Forte V. Pediatric head and neck malignancies. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):471-6. doi: 10.1097/MOO.0b013e3283323893.
PubMed 19745735Gosepath J, Spix C, Talebloo B, Blettner M, Mann WJ. Incidence of childhood cancer of the head and neck in Germany. Ann Oncol. 2007 Oct;18(10):1716-21. doi: 10.1093/annonc/mdm278. Epub 2007 Jul 28.
PubMed 17660492
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
- Malignant Head and Neck Tumors in Children: A Retrospective Study
- ClinicalTrials.gov ID
- NCT02557048
- Acronym / sponsor ID
- Ped Head Neck Malig
- Conditions
- Head and Neck Neoplasms, Cancer of Head and Neck, Cancer of the Head and Neck, Head and Neck Cancer, Neoplasms, Head and Neck
- Keywords
- Childhood Cancer, Head and Neck Tumors, Pediatric Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Sep 2015 (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 the study is to identify demographic characteristics, various histopathologies, and site preferences for each disease entity of malignant head and neck tumors in pediatric oncology patients \& treatment outcomes in these patients, according to experience at South Egypt Cancer Institute which is the largest referral site in Upper Egypt.
Detailed description
Background:
Although head and neck masses represent a common entity in children, malignancy is uncommon. Only very limited data are available in the literature on the incidence of childhood cancer of the head and neck worldwide.
Data from the United States National Cancer Institute database suggest that the head and neck are involved in 12 % of all childhood malignancies. The most common pediatric head and neck malignancies include Non Hodgkin lymphomas, Hodgkin lymphomas, rhabdomyosarcomas, thyroid malignancies, nasopharyngeal carcinomas (NPCs), salivary gland malignancies, and neuroblastomas.
Patients \& Methods:
A hospital-based study, involving Pediatric cancer patients, those diagnosed with malignant tumors of the head \& neck, 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.
Clinico-laboratory data for each hisopathologic disease entity of various head \& neck malignancies will be gathered. The demographic distribution for each disease entity in accordance with gender \& age, and site preferences in these disease entities will be recorded. Treatment received \& treatment outcomes will be verified and absolute frequencies \& relative incidence of these disease entities will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A hospital-based study, involving Pediatric cancer patients, those diagnosed with malignant tumors of the head \& neck, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical reports will be retrospectively reviewed for data collection.
Key inclusion criteria (2 listed)
- Patients whose age less than 19 years.
- Patients diagnosed with a primary malignant tumor of the head \& neck.
Key exclusion criteria (4 listed)
- Patients whose age more than 18 years.
- Patients diagnosed with a malignant disease primarily arising from the bone marrow.
- Patients diagnosed with tumors of the central nervous system.
- Patients diagnosed with retinoblastoma.
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.
- Background: PubMed 19745735Chadha NK, Forte V. Pediatric head and neck malignancies. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):471-6. doi: 10.1097/MOO.0b013e3283323893.
- Background: PubMed 17660492Gosepath J, Spix C, Talebloo B, Blettner M, Mann WJ. Incidence of childhood cancer of the head and neck in Germany. Ann Oncol. 2007 Oct;18(10):1716-21. doi: 10.1093/annonc/mdm278. Epub 2007 Jul 28.
Related trials for Head and Neck Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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 Head and Neck Neoplasms and Cancer of Head and Neck, 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 4 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 NCT02557048, which also lists 2 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.