LeukemiaNCT04756258
Early Diagnosis of Leukemic Children Patients Based on Clinical, Age Estimation and Radiographical Evaluation of Oral Affection
An observational study of Leukemia, run by Tanta University at 1 site in Egypt.
Trial summary
Early diagnosis of leukemia which is malignant tumor affecting bone especially in children is import to allow early intervention improving prognosis. It is known that leukemic patients suffer from clinical signs as anemia, thrombocytopenia, and pronounced hepatosplenomegaly or lymphadenopathy. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Leukemia
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2020to 22 Oct 2020
- How long will I take part?
- 1 Day
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: ten Children leukemic patients selected from hematology Unit of faculty of medicine, Tanta university revealing anemia or abnormal WBCs confirmed by bone marrow aspiration biopsy, these Children patients examined orally for any oral pathology as gingival masses, oral ulceration, bone resorption, teeth mobility, and assessed radiographically by panoramic and CBCT for age estimation , bone density to help in their early diagnose if they came to the dentist
Who may be able to join
- 1-Children will be aged from 6-10 years 2 Children diagnosed with leukemia but they don't start treatment yet
- -
Who cannot join
- Children below or above the age
- Children already diagnosed by leukemia and started treatment
- Children diagnosed by other bone lesions showing osteolytic bone or anemia as thalassemia or sickle cell anemia or any other bone pathology
Trial locations and contacts
1 site in 1 country.
About this study
Early diagnosis of leukemia which is malignant tumor affecting bone especially in children is import to allow early intervention improving prognosis. It is known that leukemic patients suffer from clinical signs as anemia, thrombocytopenia, and pronounced hepatosplenomegaly or lymphadenopathy. However, sometimes these clinical signs may be not clearly manifested and may look like anemia. The early diagnosis could be achieved through dentist by accessing clinical and radiographical signs such as oral masses, gingival bleeding /or enlargement and oral ulceration with radiographical features including focal or generalized osteolysis of bone with presence of moth eating appearance and even with abnormal teeth chronology regarding teeth morphology, germ formation of permanent teeth and their sequence of eruption. Therefore, accessing of these special clinical and radiographical features by the dentist could help in early diagnosis of leukemic children patients
Read the detailed description
Ten children patients suffer from leukemia selected after initial diagnosis from hematology unit of faculty of medicine, Tanta university based on their clinical signs such as; bone pain, fatigability, lymph node enlargement…etc., with abnormal CBC revealing anemia or abnormal WBCs. These patients accessed clinically for oral signs and accessed radiographically using panoramic radiographs and cone beam computed tomography (CBCT) to evaluate chronology and bone density.
- Conditions
- Leukemia
- Medical subject headings
- Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to diagnose leukemic child patients who don't have manifesting systemic clinical signs from their clinical and radiographical oral signs
theses leukemic child patients could be diagnosed based on observation of oral signs such as oral masse, ulcers lake normal red hallow, bone loss around teeth without presence of local factors, abnormal teeth chronology regarding teeth morphology and eruption, germ formation of permanent teeth and their sequence of eruption and abnormal bone density through panoramic and CBCT images
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start30 Jan 2020
- Primary completion22 Oct 2020
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab ghouraba, Tanta University
- Investigators
- rehab f ghouraba, PHD, Principal investigator, Tanta university, faculty of dentistry, Oral medicine clinicrehab f ghouraba, Principal investigator, Tanta university, faculty of dentistry, Oral medicine clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756258
- Sponsor's protocol ID
- 222
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Leukemic Children Patients Based on Clinical, Age Estimation and Radiographical Evaluation of Oral Affection
- ClinicalTrials.gov ID
- NCT04756258
- Acronym / sponsor ID
- 222
- Conditions
- Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 16 Feb 2021 (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.
Early diagnosis of leukemia which is malignant tumor affecting bone especially in children is import to allow early intervention improving prognosis. It is known that leukemic patients suffer from clinical signs as anemia, thrombocytopenia, and pronounced hepatosplenomegaly or lymphadenopathy. However, sometimes these clinical signs may be not clearly manifested and may look like anemia. The early diagnosis could be achieved through dentist by accessing clinical and radiographical signs such as oral masses, gingival bleeding /or enlargement and oral ulceration with radiographical features including focal or generalized osteolysis of bone with presence of moth eating appearance and even with abnormal teeth chronology regarding teeth morphology, germ formation of permanent teeth and their sequence of eruption. Therefore, accessing of these special clinical and radiographical features by the dentist could help in early diagnosis of leukemic children patients
Detailed description
Ten children patients suffer from leukemia selected after initial diagnosis from hematology unit of faculty of medicine, Tanta university based on their clinical signs such as; bone pain, fatigability, lymph node enlargement…etc., with abnormal CBC revealing anemia or abnormal WBCs. These patients accessed clinically for oral signs and accessed radiographically using panoramic radiographs and cone beam computed tomography (CBCT) to evaluate chronology and bone density.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ten Children leukemic patients selected from hematology Unit of faculty of medicine, Tanta university revealing anemia or abnormal WBCs confirmed by bone marrow aspiration biopsy, these Children patients examined orally for any oral pathology as gingival masses, oral ulceration, bone resorption, teeth mobility, and assessed radiographically by panoramic and CBCT for age estimation , bone density to help in their early diagnose if they came to the dentist
Key inclusion criteria (2 listed)
- 1-Children will be aged from 6-10 years 2 Children diagnosed with leukemia but they don't start treatment yet
- -
Key exclusion criteria (3 listed)
- Children below or above the age
- Children already diagnosed by leukemia and started treatment
- Children diagnosed by other bone lesions showing osteolytic bone or anemia as thalassemia or sickle cell anemia or any other bone pathology
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
Ability to diagnose leukemic child patients who don't have manifesting systemic clinical signs from their clinical and radiographical oral signs
Time frame: one year
theses leukemic child patients could be diagnosed based on observation of oral signs such as oral masse, ulcers lake normal red hallow, bone loss around teeth without presence of local factors, abnormal teeth chronology regarding teeth morphology and eruption, germ formation of permanent teeth and their sequence of eruption and abnormal bone density through panoramic and CBCT images
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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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.
rehab f ghouraba, PHD principal investigator
Tanta university, faculty of dentistry, Oral medicine clinic
rehab f ghouraba principal investigator
Tanta university, faculty of dentistry, Oral medicine clinic
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 Leukemia, run by Tanta 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 3 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: finished, as of the sponsor's last update on 16 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to diagnose leukemic child patients who don't have manifesting systemic clinical signs from their clinical and radiographical oral signs (time frame: one year). 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 16 Feb 2021.