Lyphoid DisordersNCT03720977
Diagnostic Value and Biological Significant of cd71 in Lymphoid Disorders
An observational study of Lyphoid Disorders and cd71, run by Marwa Aboelim Shafeik.
Trial summary
CD71 is expressed on activated B and T cells, macrophages, reticulocytes, erythroid precursors, and malignant tissues. , reflecting the requirement for iron in hemoglobin. , CD71 expression is upregulated on immature proliferating cells and low levels on resting mature lymphocytes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lyphoid Disorders, cd71
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Dec 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: confidence level 95 sample size 139
Who may be able to join
- all patients wiil be diagnosed lymphoid disorders
Who cannot join
- not present
Trial locations and contacts
No sites are listed yet.
Tagreed kamal, dr contact
About this study
Official title: Diagnostic Value and Biological Significant of cd71 in Lymphoid Dis Order
CD71 is expressed on activated B and T cells, macrophages, reticulocytes, erythroid precursors, and malignant tissues. , reflecting the requirement for iron in hemoglobin. , CD71 expression is upregulated on immature proliferating cells and low levels on resting mature lymphocytes. In addition to this general function, CD71 appears to play a costimulatory role in T cell activation and receptor for IgA1 antibodies So it is growth receptor that may help in diagnosis of lymphoid disorder and in differentiation of malignant and benign that will be studied investigate CD71 expression in lymphoid disorders and its diagnostic value ,we from collect data patient and do rotune examination
Read the detailed description
- Routine investigations for diagnosis:
- CBC.
- Bone marrow aspiration morphology.
- Cytochemistry.
- Flow cytometry immunophenotyping.
- Bone marrow biopsy when indicated.
- Special investigation is flow cytometry examination of CD71 expression. sample size calculation ; sample size cases 39 sample size controls 39 total sample size 79 sample will be collected from patient in hospital university ,Data will be analysed by SPSS program
- Conditions
- Lyphoid Disorders, cd71
What is being measured
The primary outcome is the main question the study is designed to answer.
determin diagnostic value of cd71 in lymphoid disorder
Routine investigations for diagnosis:
CBC. Bone marrow aspiration morphology. Cytochemistry. Flow cytometry immunophenotyping. Bone marrow biopsy when indicated. Special investigation is flow cytometry examination of CD71 expression.
total sample size 79 person .sample will be collected from patient in hospital university ,Data will be analysed by SPSS program it is growth receptor is expressed on activated B and T cells, macrophages, reticulocytes, erythroid precursors, and malignant tissues
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lyphoid DisordersStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marwa Aboelim Shafeik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Aboelim Shafeik, Assiut University
- Investigators
- Maged Salah, Prof, Study director, Assiut University .clinical pathologydepartment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720977
- Sponsor's protocol ID
- diagnostic value of cd71
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: immunophenotyping by flow cytometry of cd71
Publications
Zhang Q, Steensma DP, Yang J, Dong T, Wu MX. Uncoupling of CD71 shedding with mitochondrial clearance in reticulocytes in a subset of myelodysplastic syndromes. Leukemia. 2019 Jan;33(1):217-229. doi: 10.1038/s41375-018-0204-z. Epub 2018 Jul 26.
PubMed 30050123Salzberger W, Martrus G, Bachmann K, Goebels H, Hess L, Koch M, Langeneckert A, Lunemann S, Oldhafer KJ, Pfeifer C, Poch T, Richert L, Schramm C, Wahib R, Bunders MJ, Altfeld M. Tissue-resident NK cells differ in their expression profile of the nutrient transporters Glut1, CD98 and CD71. PLoS One. 2018 Jul 20;13(7):e0201170. doi: 10.1371/journal.pone.0201170. eCollection 2018.
PubMed 30028872Dunsmore G, Koleva P, Ghobakhloo N, Sutton R, Ambrosio L, Meng X, Hotte N, Nguyen V, Madsen KL, Dieleman LA, Huang V, Elahi S. Lower Abundance and Impaired Function of CD71+ Erythroid Cells in Inflammatory Bowel Disease Patients During Pregnancy. J Crohns Colitis. 2019 Feb 1;13(2):230-244. doi: 10.1093/ecco-jcc/jjy147.
PubMed 30272151
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value and Biological Significant of cd71 in Lymphoid Dis Order
- ClinicalTrials.gov ID
- NCT03720977
- Acronym / sponsor ID
- diagnostic value of cd71
- Conditions
- Lyphoid Disorders, cd71
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Marwa Aboelim ShafeikUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 26 Oct 2018 (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.
CD71 is expressed on activated B and T cells, macrophages, reticulocytes, erythroid precursors, and malignant tissues. , reflecting the requirement for iron in hemoglobin. , CD71 expression is upregulated on immature proliferating cells and low levels on resting mature lymphocytes. In addition to this general function, CD71 appears to play a costimulatory role in T cell activation and receptor for IgA1 antibodies So it is growth receptor that may help in diagnosis of lymphoid disorder and in differentiation of malignant and benign that will be studied investigate CD71 expression in lymphoid disorders and its diagnostic value ,we from collect data patient and do rotune examination
Detailed description
- Routine investigations for diagnosis:
- CBC.
- Bone marrow aspiration morphology.
- Cytochemistry.
- Flow cytometry immunophenotyping.
- Bone marrow biopsy when indicated.
- Special investigation is flow cytometry examination of CD71 expression. sample size calculation ; sample size cases 39 sample size controls 39 total sample size 79 sample will be collected from patient in hospital university ,Data will be analysed by SPSS program
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- confidence level 95 sample size 139
Key inclusion criteria (1 listed)
- all patients wiil be diagnosed lymphoid disorders
Key exclusion criteria (1 listed)
- not present
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
determin diagnostic value of cd71 in lymphoid disorder
Time frame: baseline
Routine investigations for diagnosis: CBC. Bone marrow aspiration morphology. Cytochemistry. Flow cytometry immunophenotyping. Bone marrow biopsy when indicated. Special investigation is flow cytometry examination of CD71 expression. total sample size 79 person .sample will be collected from patient in hospital university ,Data will be analysed by SPSS program it is growth receptor is expressed on activated B and T cells, macrophages, reticulocytes, erythroid precursors, and malignant tissues
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Background: PubMed 30050123Zhang Q, Steensma DP, Yang J, Dong T, Wu MX. Uncoupling of CD71 shedding with mitochondrial clearance in reticulocytes in a subset of myelodysplastic syndromes. Leukemia. 2019 Jan;33(1):217-229. doi: 10.1038/s41375-018-0204-z. Epub 2018 Jul 26.
- Background: PubMed 30028872Salzberger W, Martrus G, Bachmann K, Goebels H, Hess L, Koch M, Langeneckert A, Lunemann S, Oldhafer KJ, Pfeifer C, Poch T, Richert L, Schramm C, Wahib R, Bunders MJ, Altfeld M. Tissue-resident NK cells differ in their expression profile of the nutrient transporters Glut1, CD98 and CD71. PLoS One. 2018 Jul 20;13(7):e0201170. doi: 10.1371/journal.pone.0201170. eCollection 2018.
- Results publication: PubMed 30272151Dunsmore G, Koleva P, Ghobakhloo N, Sutton R, Ambrosio L, Meng X, Hotte N, Nguyen V, Madsen KL, Dieleman LA, Huang V, Elahi S. Lower Abundance and Impaired Function of CD71+ Erythroid Cells in Inflammatory Bowel Disease Patients During Pregnancy. J Crohns Colitis. 2019 Feb 1;13(2):230-244. doi: 10.1093/ecco-jcc/jjy147.
- Individual participant dataSharing planned: No. immunophenotyping by flow cytometry of cd71
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.
Tagreed kamal, dr contact
Maged Salah, Prof study director
Assiut University .clinical pathologydepartment
Questions about this trial
What is this clinical trial studying?
An observational study of Lyphoid Disorders and cd71, run by Marwa Aboelim Shafeik.
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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Marwa Aboelim (01012636292, marwaaboelim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determin diagnostic value of cd71 in lymphoid disorder (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 NCT03720977, which also lists 3 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 26 Oct 2018.