Recurrent Head and Neck Squamous Cell CarcinomaNCT06465030
Identification of Pattern and Factors Affecting Recurrence in Head and Neck Carcinoma
An observational study of Recurrent Head and Neck Squamous Cell Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
The study will evaluate the local experiences in treatment of head and neck carcinoma by retrospectively analyzing the incidence and location of recurrence, and also studying factors affecting this recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Squamous Cell Carcinoma
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to Jun 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with recurrent head and neck cancer after radical treatment by IMRT and VMAT, in Sohag city.
Who may be able to join
- Adults aged more than 18 years. Patients with primary non nasopharyngeal head and neck squamous cell carcinoma. Patients who were intended to receive radical treatment delivered by IMRT and VMAT techniques.
Who cannot join
- Adults who had double malignancies. Metastatic HNSCC cases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Faculty of Medicine
Sohag
Reem Gamal, 01094086660, reemgamal4996@gmail.com
Walaa Gamal, lecturer, 01001316515
About this study
Official title: Identification of Pattern and Factors Affecting Recurrence of Head and Neck Carcinoma After Radical IMRT and VMAT
The study will evaluate the local experiences in treatment of head and neck carcinoma by retrospectively analyzing the incidence and location of recurrence, and also studying factors affecting this recurrence.
Read the detailed description
The investigators will evaluate the local experience in treatment of head and neck SCC by retrospectively analyzing the incidence and location of recurrence, either; local recurrence (LR), regional recurrence (RR), or distant mets in eligible head and neck cancer patients treated with IMRT and VMAT in the period from 2018 till 2022 to allow a follow-up for at least 1 year.
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of relapse in recurrent head and neck squamous cell carcinoma, evident clinically and measured by images "US,CT, MRI and endoscopy".
Local, locoregional recurrence by MRI neck and CT Neck and distant recurrence by pan CTs.
Measured: At least obsevation of 1 year FU of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start15 Jul 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Gamal Mohamed, Sohag University
- Investigators
- Reem Gamal, M.B.B.Ch, Principal investigator, Sohag university hospital, oncology and nuclear medicine department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465030
- Sponsor's protocol ID
- Soh-Med-24-04-017MS
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Pattern and Factors Affecting Recurrence of Head and Neck Carcinoma After Radical IMRT and VMAT
- ClinicalTrials.gov ID
- NCT06465030
- Acronym / sponsor ID
- Soh-Med-24-04-017MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Jun 2024 (actual)
- 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 study will evaluate the local experiences in treatment of head and neck carcinoma by retrospectively analyzing the incidence and location of recurrence, and also studying factors affecting this recurrence.
Detailed description
The investigators will evaluate the local experience in treatment of head and neck SCC by retrospectively analyzing the incidence and location of recurrence, either; local recurrence (LR), regional recurrence (RR), or distant mets in eligible head and neck cancer patients treated with IMRT and VMAT in the period from 2018 till 2022 to allow a follow-up for at least 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent head and neck cancer after radical treatment by IMRT and VMAT, in Sohag city.
Key inclusion criteria (1 listed)
- Adults aged more than 18 years. Patients with primary non nasopharyngeal head and neck squamous cell carcinoma. Patients who were intended to receive radical treatment delivered by IMRT and VMAT techniques.
Key exclusion criteria (1 listed)
- Adults who had double malignancies. Metastatic HNSCC cases.
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
Pattern of relapse in recurrent head and neck squamous cell carcinoma, evident clinically and measured by images "US,CT, MRI and endoscopy".
Time frame: At least obsevation of 1 year FU of the patient
Local, locoregional recurrence by MRI neck and CT Neck and distant recurrence by pan CTs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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.
Reem Gamal, M.B.B.Ch principal investigator
Sohag university hospital, oncology and nuclear medicine department
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 Recurrent Head and Neck Squamous Cell Carcinoma, run by Sohag 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 1 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 25 Jun 2024. 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?
Contact Reem Gamal, M.B.B.Ch (01094086660, reemgamal4996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of relapse in recurrent head and neck squamous cell carcinoma, evident clinically and measured by images "US,CT, MRI and endoscopy". (time frame: At least obsevation of 1 year FU of the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2024.