Hematologic MalignancyNCT05758207
Oral Complications in Hematological Malignancies
An observational study of Hematologic Malignancy, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the prevalence and types of oral complications found in patients diagnosed with haematological malignancy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hematologic Malignancy
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 1 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: All newly diagnosed patients elder than 18 years with hematological malignancy
Who may be able to join
- All newly diagnosed patients elder than 18 years with hematological malignancy start from January 1st 2022 to January 1st 2023 including Acute myeloid leukemia Acute lymphoblastic leukemia Chronic myeloid leukemia Chronic lymphoblastic leukemia Non-Hodgkin lymphoma Hodgkin lymphoma Multiple myeloma
Who cannot join
- Patient younger than 18 years old Patients previously diagnosed Patients refused to participate in our study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Types of Oral Complications Occuring in Hematological Malignancy Patients.:Cross Sectional Study
The aim of this study was to evaluate the prevalence and types of oral complications found in patients diagnosed with haematological malignancy
Read the detailed description
Oral lesions can be the first presentation of hematological malignancy. Dentists occasionally are the first healthcare provider that detect oral signs related to a systemic condition and thus contribute to the early diagnosis of the disease 1. Oral health can impact the progression and the outcome of haematological malignancy patients', many patients may suffer from oral infections that might affect hospital stay, treatment cost and patient prognosis 2. The oral manifestations of patients with hematological malignancy can occur due to the disease itself or as a consequence of treatment 3.
Anemia (paleness of mucosa), coagulation disorder, oral petechiae or ecchymosis, spontaneous gingival bleeding and oral infection (Ulcers and overgrowth) may be an oral manifestation of a hematologic malignancy either at diagnosis or during follow up as well as in relapse 4. The treatment of hematologic malignancy includes chemotherapy, radiotherapy, and hematopoietic stem cell transplantation (HSCT). Malignant cells are the target of antineoplastic drugs, but the oral epithelium and other cells with high mitotic rates are usually affected by the treatment. Chemotherapy and the conditioning regimen for HSCT have many adverse effects on the oral tissues depending on the type and dosage of medications 4. Oral mucositis, a common side effect of chemotherapy, causes severe pain, which is only relieved by opioids. Mucositis may appear as a generalized erythema and evolve into painful pseudomembranous ulcers. Neutropenia and thrombocytopenia are also common adverse effects of treatment, leaving patients more susceptible to oral bleeding, infections, and ulcerations. Oral mucosa pigmentation can also occur as an adverse effect of treatment 5. Considering these factors and lack of existing information, a study was designed to investigate the prevalence of oral complications problems occurring in a population of hematological malignancy patients in Assiut University Hospital.
- Conditions
- Hematologic Malignancy
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the prevalence of oral complications.
Calculate the prevalence of oral complications with special attention to infectious complications in hematological malignancy patients.
Measured: Baseline
Secondary outcomes (1)
the morbidity related to oral complication in haematological malignancy patients.
Study the morbidity related to oral complication in haematological malignancy patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start15 May 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 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 Hematologic MalignancyStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merit Rafeek Gerges Botros, Assiut University
- Investigators
- Nabila Fayek, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758207
- Sponsor's protocol ID
- Hematology malignancies
- Status last verified
- May 2023
- First submitted
- 17 Feb 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
Publications
Emodi O, Ohayon C, Bilder A, Capucha T, Wolff A, Rachmiel A. Postextraction Mucormycosis in Immunocompromised-Patient Management and Review of Literature. J Oral Maxillofac Surg. 2021 Jul;79(7):1482-1491. doi: 10.1016/j.joms.2021.01.019. Epub 2021 Jan 25.
PubMed 33617788Elad S, Zadik Y, Yarom N. Oral Complications of Nonsurgical Cancer Therapies. Atlas Oral Maxillofac Surg Clin North Am. 2017 Sep;25(2):133-147. doi: 10.1016/j.cxom.2017.04.006. No abstract available.
PubMed 28778303
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Types of Oral Complications Occuring in Hematological Malignancy Patients.:Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05758207
- Acronym / sponsor ID
- Hematology malignancies
- Conditions
- Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 Mar 2023 (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 aim of this study was to evaluate the prevalence and types of oral complications found in patients diagnosed with haematological malignancy
Detailed description
Oral lesions can be the first presentation of hematological malignancy. Dentists occasionally are the first healthcare provider that detect oral signs related to a systemic condition and thus contribute to the early diagnosis of the disease 1. Oral health can impact the progression and the outcome of haematological malignancy patients', many patients may suffer from oral infections that might affect hospital stay, treatment cost and patient prognosis 2. The oral manifestations of patients with hematological malignancy can occur due to the disease itself or as a consequence of treatment 3.
Anemia (paleness of mucosa), coagulation disorder, oral petechiae or ecchymosis, spontaneous gingival bleeding and oral infection (Ulcers and overgrowth) may be an oral manifestation of a hematologic malignancy either at diagnosis or during follow up as well as in relapse 4. The treatment of hematologic malignancy includes chemotherapy, radiotherapy, and hematopoietic stem cell transplantation (HSCT). Malignant cells are the target of antineoplastic drugs, but the oral epithelium and other cells with high mitotic rates are usually affected by the treatment. Chemotherapy and the conditioning regimen for HSCT have many adverse effects on the oral tissues depending on the type and dosage of medications 4. Oral mucositis, a common side effect of chemotherapy, causes severe pain, which is only relieved by opioids. Mucositis may appear as a generalized erythema and evolve into painful pseudomembranous ulcers. Neutropenia and thrombocytopenia are also common adverse effects of treatment, leaving patients more susceptible to oral bleeding, infections, and ulcerations. Oral mucosa pigmentation can also occur as an adverse effect of treatment 5. Considering these factors and lack of existing information, a study was designed to investigate the prevalence of oral complications problems occurring in a population of hematological malignancy patients in Assiut University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All newly diagnosed patients elder than 18 years with hematological malignancy
Key inclusion criteria (1 listed)
- All newly diagnosed patients elder than 18 years with hematological malignancy start from January 1st 2022 to January 1st 2023 including Acute myeloid leukemia Acute lymphoblastic leukemia Chronic myeloid leukemia Chronic lymphoblastic leukemia Non-Hodgkin lymphoma Hodgkin lymphoma Multiple myeloma
Key exclusion criteria (1 listed)
- Patient younger than 18 years old Patients previously diagnosed Patients refused to participate in our study
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
Calculate the prevalence of oral complications.
Time frame: Baseline
Calculate the prevalence of oral complications with special attention to infectious complications in hematological malignancy patients.
1 secondary outcome
the morbidity related to oral complication in haematological malignancy patients.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 33617788Emodi O, Ohayon C, Bilder A, Capucha T, Wolff A, Rachmiel A. Postextraction Mucormycosis in Immunocompromised-Patient Management and Review of Literature. J Oral Maxillofac Surg. 2021 Jul;79(7):1482-1491. doi: 10.1016/j.joms.2021.01.019. Epub 2021 Jan 25.
- Background: PubMed 28778303Elad S, Zadik Y, Yarom N. Oral Complications of Nonsurgical Cancer Therapies. Atlas Oral Maxillofac Surg Clin North Am. 2017 Sep;25(2):133-147. doi: 10.1016/j.cxom.2017.04.006. No abstract available.
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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.
Nabila Fayek study director
Assiut University
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 Hematologic Malignancy, 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 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 15 Aug 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?
Contact Merit Rafeek (01270240012, toot.rafeek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculate the prevalence of oral complications. (time frame: Baseline). 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 NCT05758207, 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 15 Aug 2023.