Dermatologic Disorders With Heamatologic Malignancies PatientsNCT06108622
Prevelance Of Cutaneous Disorders Among Patients With Heamatologic Malignancies
An observational study of Dermatologic Disorders With Heamatologic Malignancies Patients, run by Sohag University at 1 site in Egypt.
Trial summary
Hematologic malignancies are a diverse group of neoplasms that can have a wide range of clinical and behavioral characteristics. Infections are also a common complication of hematologic malignancies, and can manifest as cutaneous eruptions. Hair loss is a common symptom of hematological malignancies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dermatologic Disorders With Heamatologic Malignancies Patients
- What is being tested?
- cbc ,u\s renalor hepatic function test if needed
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2023to Nov 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: * A cross - sectional study will include patients who attending and/or admitted to Clinical Oncology and Nuclear Medicine Department Sohag university Hospital. * The study protocol will be approved by the Local Ethics and scientific Committee in Sohag faculty of medicine . * Written informed consents will be obtained from all patients
Who may be able to join
- Age: all age groups.
- Sex: both sex will be included.
- Patients with confirmed diagnosis of haematological malignancies ethier clinically or laboratory.
Who cannot join
- Pregnancy., • Patients with medical comorbidities (liver ,renal ,thyroid abnormalities ,other malignancies)
Trial locations and contacts
1 site in 1 country.
soha H abodahab, assistant professor contact
About this study
Hematologic malignancies are a diverse group of neoplasms that can have a wide range of clinical and behavioral characteristics. Infections are also a common complication of hematologic malignancies, and can manifest as cutaneous eruptions. Hair loss is a common symptom of hematological malignancies. Changes in the nails can also occur in patients with hematological malignancies. Chemotherapy and radiotherapy are two common treatments for hematological malignancies. patients may experience a wide range of side effects, including hair loss, changes in the nails, and mucositis (
Read the detailed description
hematologic malignancies are a diverse group of neoplasms that can have a wide range of clinical and behavioral characteristics. The skin is often involved in these diseases, either through direct infiltration by malignant cells or through non-specific changes such as pallor and ecchymosis. Cutaneous involvement can have a significant impact on the quality of life of patients with hematologic malignancies and can also compromise prognosis in certain cases Cutaneous manifestations of hematologic malignancies have become increasingly common. This is partly due to the availability of new drugs that have improved the prognosis of these patients, but also come with an increased risk of skin toxicity. Furthermore, the effectiveness of these therapies has led to increased survival, which in turn has allowed for the emergence of skin eruptions that were not as frequently seen in the past due to the shorter duration of the natural history of cancer Some of the most common manifestations include petechiae, purpura, erythroderma, palpable purpura, Sweet's syndrome and paraneoplastic pemphigus Infections are also a common complication of hematologic malignancies, and can manifest as cutaneous eruptions. For example, patients with leukemia and other blood cancers are at increased risk for developing fungal infections such as candidiasis and aspergillosis, which can present as red, scaly, and itchy skin. Other infections, such as cellulitis, can also occur as a complication of hematologic malignancies and can present with red, swollen, and warm skin Hair loss is a common symptom of hematological malignancies. The cancer cells can interfere with the growth and maintenance of hair follicles, leading to hair loss. Hair loss can be patchy or diffuse, and can occur on the2 scalp, face, or body. In some cases, hair loss can be 2ry to treatment or sign of the progression of the disease. Changes in the nails can also occur in patients with hematological malignancies. The nails may become discolored, brittle, or develop ridges or grooves. In some cases, the nails may also separate from the nail bed. These changes are typically caused by the cancer cells affecting the blood flow to the nails or by the cancer treatment Mucous membranes can also be affected by hematological malignancies. The cancer cells can cause inflammation, soreness, and dryness in the mucous membranes, leading to a condition called mucositis. Mucositis can make it difficult to eat or speak, and can increase the risk of infection. Chemotherapy and radiotherapy are two common treatments for hematological malignancies. These treatments are designed to kill cancer cells or shrink tumors, but they can also affect healthy cells in the body. As a result, patients may experience a wide range of side effects, including hair loss, changes in the nails, and mucositis
. Other common side effects of chemotherapy include nausea, vomiting, fatigue, and an increased risk of infection. Radiation therapy can cause skin reactions, fatigue, and a risk of secondary cancer. Side effects can vary widely depending on the type of cancer and the specific drugs and radiation regimens used. Each patient may experience different side effects, and the intensity and duration of the side effects also vary
- Being tested
- cbc ,u\s renalor hepatic function test if needed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cbc ,u\s renalor hepatic function test if neededDiagnostic test
just blood sample if the case needed
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevelance Of Cutaneous Disordera Amog Patients with Heamatologic Malignancies
- A cross - sectional study will include patients who attending and/or admitted to Clinical Oncology and Nuclear Medicine Department Sohag university Hospital.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionNov 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 Dermatologic Disorders With Heamatologic Malignancies PatientsStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Taha, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108622
- Sponsor's protocol ID
- soh-Med-23-10-06MS
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atkins S, He F. Chemotherapy and Beyond: Infections in the Era of Old and New Treatments for Hematologic Malignancies. Infect Dis Clin North Am. 2019 Jun;33(2):289-309. doi: 10.1016/j.idc.2019.01.001. Epub 2019 Mar 30.
PubMed 30935703Didona D, Fania L, Didona B, Eming R, Hertl M, Di Zenzo G. Paraneoplastic Dermatoses: A Brief General Review and an Extensive Analysis of Paraneoplastic Pemphigus and Paraneoplastic Dermatomyositis. Int J Mol Sci. 2020 Mar 21;21(6):2178. doi: 10.3390/ijms21062178.
PubMed 32245283Dika E, Patrizi A, Veronesi G, Manuelpillai N, Lambertini M. Malignant cutaneous tumours of the scalp: always remember to examine the head. J Eur Acad Dermatol Venereol. 2020 Oct;34(10):2208-2215. doi: 10.1111/jdv.16330. Epub 2020 Apr 7.
PubMed 32119157Liu YQ, Wang XL, He DH, Cheng YX. Protection against chemotherapy- and radiotherapy-induced side effects: A review based on the mechanisms and therapeutic opportunities of phytochemicals. Phytomedicine. 2021 Jan;80:153402. doi: 10.1016/j.phymed.2020.153402. Epub 2020 Oct 31.
PubMed 33203590
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance Of Cutaneous Disorders Among Patients With Heamatologic Malignancies
- ClinicalTrials.gov ID
- NCT06108622
- Acronym / sponsor ID
- soh-Med-23-10-06MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 31 Oct 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.
Hematologic malignancies are a diverse group of neoplasms that can have a wide range of clinical and behavioral characteristics. Infections are also a common complication of hematologic malignancies, and can manifest as cutaneous eruptions. Hair loss is a common symptom of hematological malignancies. Changes in the nails can also occur in patients with hematological malignancies. Chemotherapy and radiotherapy are two common treatments for hematological malignancies. patients may experience a wide range of side effects, including hair loss, changes in the nails, and mucositis (
Detailed description
hematologic malignancies are a diverse group of neoplasms that can have a wide range of clinical and behavioral characteristics. The skin is often involved in these diseases, either through direct infiltration by malignant cells or through non-specific changes such as pallor and ecchymosis. Cutaneous involvement can have a significant impact on the quality of life of patients with hematologic malignancies and can also compromise prognosis in certain cases Cutaneous manifestations of hematologic malignancies have become increasingly common. This is partly due to the availability of new drugs that have improved the prognosis of these patients, but also come with an increased risk of skin toxicity. Furthermore, the effectiveness of these therapies has led to increased survival, which in turn has allowed for the emergence of skin eruptions that were not as frequently seen in the past due to the shorter duration of the natural history of cancer Some of the most common manifestations include petechiae, purpura, erythroderma, palpable purpura, Sweet's syndrome and paraneoplastic pemphigus Infections are also a common complication of hematologic malignancies, and can manifest as cutaneous eruptions. For example, patients with leukemia and other blood cancers are at increased risk for developing fungal infections such as candidiasis and aspergillosis, which can present as red, scaly, and itchy skin. Other infections, such as cellulitis, can also occur as a complication of hematologic malignancies and can present with red, swollen, and warm skin Hair loss is a common symptom of hematological malignancies. The cancer cells can interfere with the growth and maintenance of hair follicles, leading to hair loss. Hair loss can be patchy or diffuse, and can occur on the2 scalp, face, or body. In some cases, hair loss can be 2ry to treatment or sign of the progression of the disease. Changes in the nails can also occur in patients with hematological malignancies. The nails may become discolored, brittle, or develop ridges or grooves. In some cases, the nails may also separate from the nail bed. These changes are typically caused by the cancer cells affecting the blood flow to the nails or by the cancer treatment Mucous membranes can also be affected by hematological malignancies. The cancer cells can cause inflammation, soreness, and dryness in the mucous membranes, leading to a condition called mucositis. Mucositis can make it difficult to eat or speak, and can increase the risk of infection. Chemotherapy and radiotherapy are two common treatments for hematological malignancies. These treatments are designed to kill cancer cells or shrink tumors, but they can also affect healthy cells in the body. As a result, patients may experience a wide range of side effects, including hair loss, changes in the nails, and mucositis
. Other common side effects of chemotherapy include nausea, vomiting, fatigue, and an increased risk of infection. Radiation therapy can cause skin reactions, fatigue, and a risk of secondary cancer. Side effects can vary widely depending on the type of cancer and the specific drugs and radiation regimens used. Each patient may experience different side effects, and the intensity and duration of the side effects also vary
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- * A cross - sectional study will include patients who attending and/or admitted to Clinical Oncology and Nuclear Medicine Department Sohag university Hospital. * The study protocol will be approved by the Local Ethics and scientific Committee in Sohag faculty of medicine . * Written informed consents will be obtained from all patients
Key inclusion criteria (3 listed)
- Age: all age groups.
Key exclusion criteria (1 listed)
- Pregnancy., • Patients with medical comorbidities (liver ,renal ,thyroid abnormalities ,other malignancies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cbc ,u\s renalor hepatic function test if neededjust blood sample if the case needed | Diagnostic test | – |
Primary outcome
Prevelance Of Cutaneous Disordera Amog Patients with Heamatologic Malignancies
Time frame: 1 year
- A cross - sectional study will include patients who attending and/or admitted to Clinical Oncology and Nuclear Medicine Department Sohag university Hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 30935703Atkins S, He F. Chemotherapy and Beyond: Infections in the Era of Old and New Treatments for Hematologic Malignancies. Infect Dis Clin North Am. 2019 Jun;33(2):289-309. doi: 10.1016/j.idc.2019.01.001. Epub 2019 Mar 30.
- Background: PubMed 32245283Didona D, Fania L, Didona B, Eming R, Hertl M, Di Zenzo G. Paraneoplastic Dermatoses: A Brief General Review and an Extensive Analysis of Paraneoplastic Pemphigus and Paraneoplastic Dermatomyositis. Int J Mol Sci. 2020 Mar 21;21(6):2178. doi: 10.3390/ijms21062178.
- Background: PubMed 32119157Dika E, Patrizi A, Veronesi G, Manuelpillai N, Lambertini M. Malignant cutaneous tumours of the scalp: always remember to examine the head. J Eur Acad Dermatol Venereol. 2020 Oct;34(10):2208-2215. doi: 10.1111/jdv.16330. Epub 2020 Apr 7.
- Background: PubMed 33203590Liu YQ, Wang XL, He DH, Cheng YX. Protection against chemotherapy- and radiotherapy-induced side effects: A review based on the mechanisms and therapeutic opportunities of phytochemicals. Phytomedicine. 2021 Jan;80:153402. doi: 10.1016/j.phymed.2020.153402. Epub 2020 Oct 31.
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.
soha H abodahab, assistant professor contact
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 Dermatologic Disorders With Heamatologic Malignancies Patients, 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 3 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 31 Oct 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 alaa M Taha, resident (01143323539, alaa011006@med.sohag.edue.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevelance Of Cutaneous Disordera Amog Patients with Heamatologic Malignancies (time frame: 1 year). 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 NCT06108622, 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 31 Oct 2023.