Philadelphia Negative Myeloproliferative NeoplasmsNCT05401864
Characteristics of Patients With Philadelphia Negative Myeloproliferative Neoplasms at Assiut University Hospital
An observational study of Philadelphia Negative Myeloproliferative Neoplasms, run by Assiut University.
Trial summary
Classic Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs) are a family of clonal chronic hematologic malignancies that include. polycythemia vera (PV), essential thrombocythemia (ET), and primary. Myelofibrosis (MF) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Philadelphia Negative Myeloproliferative Neoplasms
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Jun 2024
- How long will I take part?
- 3 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Philadelphia negative myloproliferative neoplasms at Assuit university hospital
Who may be able to join
- Patients with Philadelphia negative above 18yrs old who were attend at our unit over 2 years duration.
Who cannot join
- All pt with Philadelphia positive and below 18.
About this study
Classic Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs) are a family of clonal chronic hematologic malignancies that include. polycythemia vera (PV), essential thrombocythemia (ET), and primary. Myelofibrosis (MF) . The classic MPNs historically have predominantly been diagnosed in older adults, with a median age at diagnosis of 60-72 years . Adults less than 40 years of age make up a largely underrepresented and therefore less studied subset of patients constituting 2.2-6.6% of yearly MPN cases in population- based study. These estimates are lower than incidence rate among patients between 40 and 49 years of age (9.1-10%), and have remained largely unchanged over the past four decades . However, with increasing trends in MPN incidence consequent to increased diagnostic recognition, better pathobiologic understanding, and more frequent JAK2/CALR/MPL mutational testing and newly revised WHO diagnostic criteria, it is conceivable that MPNs may be diagnosed at a higher frequency, in the younger patients, over time.
Read the detailed description
Diagnosis of MPN according to the revised 2008 WHO criteria is based on a. combination of clinical, morphological, and molecular parameters ( Cardinal features of Philadelphia chromosome-negative MPN are increased red blood cell (RBC). production in PV, sustained thrombocytosis in ET, and bone marrow (BM) fibrosis in PMF. Molecular markers, such as JAK2 V617F, JAK2 exon 12, and MPL mutations, have increased our knowledge of the pathogenesis of MPNs as well as the accuracy of diagnosis. Furthermore, many recent studies have reported that the calreticulin mutation (mutation in exon 9 of CALR) is found in the majority of patients with MPN with non mutated JAK2 . There are many controversies with regard to the subjectivity and the lack of reproducibility of the histological criteria. And BM assessment is not always needed, especially in PV. However, histologic evaluation of the pathologic features of megakaryocytic, granulocytic, and erythroid series and cellularity is important in differentiating MPNs, especially ET and PMF . Sometimes, patients with occult MPN present with normal blood counts because of gastrointestinal bleeding and associated iron deficiency, splenomegaly, or simply because they are in an early stage of the disorder . In cases of clinically suspicious MPN, such as intra-abdominal thrombosis with normal blood counts, careful investigation is needed.
diagnostic criteria for myeloproliferative (World Health Organization) 2008. Polycythemia refers to an increase in the number of red blood cells in the body. The extra cell cause the blood to be thicker, and this, in turn, increases the risk of other health issues, such as blood clots.
Maior criteria including. Hemoglobin > 18.5 g/dL (men), > 16.5 g/dL (women) or Presence of JAK2 V617F or JAK2 exon 12 mutation Minor criteria: BM hypercellularity with trilineage myeloproliferation Subnormal serum erythropoitin. Endogenous erythroid colony formation in vitro.
Management of polycythemia: The most common treatment for polychythemia vera is having frequent blood withdrawals, using a needle in a vein (phlebotomy).
Drugs that reduce the number of red blood cells If phlebotomy alone doesn't help enough, your doctor may suggest medications that can reduce the number of red blood cells in your bloodstream. Examples include: Hydroxyruea (Droxia, Hydrea), Interferon alfa-2b (Intron A), Ruxolitinib (Jakafi), Busulfan (Busulfex, Myleran) .
Primary myelofibrosis (PMF) is a rare bone marrow disorder that is characterized by abnormalities in blood cell production (hematopoiesis) and scarring (formation of fibrous tissue) within the bone marrow. Bone marrow is the soft, spongy tissue that fills the center of most bones. Major criteria including. Megakaryocyte proliferation and atypiab, accompanied by either reticulin and/or collagen fibrosis, orc Not meeting WHO criteria for PV, CML, MDS, or other myeloid neoplasm Demonstration of JAK2 V617F or other clonal marker or no evidence of bone marrow fibrosis.
prognosis scoring was the international prognostic scoring system (IPSS). IPSS was first produced in 2009 and was designed for application at the time of diagnosis. This IPSS was the result of data from 1054 consecutively diagnosed patients with PMF from 1980 to 2007. 4 risk groups were identified, with median survivals ranging from 23 years (high-risk) to 11.3 months (low-risk). Abnormal cytogenetic findings did not appear to affect patient outcomes. IPSS included five risk factors: age >65 years, hemoglobin <10 g/dl, leukocyte count >25 x 109/L, circulating blasts ≥1% and constitutional symptoms. In 2010, DIPSS was adapted from IPSS, which allowed clinicians to use prognostic scoring at any time in the clinical course. Both IPSS and DIPSS (Dynamic IPSS) used the same five clinical risk factors to determine patient prognosis.
Management of mylofibrosis: Low-risk myelofibrosis may not require immediate treatment, while people with high-risk myelofibrosis may consider an aggressive treatment, such as bone marrow transplant. For intermediate-risk myelofibrosis, treatment is usually directed at managing symptoms. Immediate treatment may not be necessary Myelofibrosis treatment may not be necessary if you aren't experiencing symptoms. You might not need treatment right away if you don't have an enlarged spleen and you don't have anemia or your anemia is very mild. Rather than treatment, your doctor is likely to monitor your health closely through regular checkups Treatments for anemia: Blood transfusions, Androgen therapy, Thalidomide and related medications.
Treatments for an enlarged spleen: Chemotherapy, Targeted drug therapy, (splenectomy). If your spleen becomes so large, Radiation therapy. Bone marrow transplant.
Essential thrombocytosis (ET), or primary thrombocythemia, is a rare disorder in which the body produces too many platelets for unknown reasons. This can cause abnormal blood clotting or bleeding. Majorcriteria: Sustained platelet count > 450 × 109/LProliferation of megakaryocytes with enlarged, mature morphology Not meeting WHO criteria for PV, PMF, CML, MDS or other myeloid neoplasm Demonstration of JAK2 V617F or other clonal marker, or no evidence for reactive Thrombocytosis. Patients with low-risk ET are usually managed with low-dose aspirin, whereas treatment of high-risk ET is based on the use of cytoreductive therapy, with hydroxyurea as the drug of choice and IFN-α being reserved for young patients or pregnant women
What is being measured
The primary outcome is the main question the study is designed to answer.
characteristics data of philadilphia negative myloproleferative neoplasm
Characteristics data of philadilphia negative myloproleferative neoplasm admitted inassiut university hospital in 2years in single center experience this data including age .sex ipss score and management of MPN
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Philadelphia Negative Myeloproliferative NeoplasmsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZeinabMekhemerTagBakr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401864
- Sponsor's protocol ID
- philadelphia negative MPNS
- Status last verified
- Jun 2022
- First submitted
- 30 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tefferi A, Pardanani A. Myeloproliferative Neoplasms: A Contemporary Review. JAMA Oncol. 2015 Apr;1(1):97-105. doi: 10.1001/jamaoncol.2015.89.
PubMed 26182311Tefferi A. Primary myelofibrosis: 2017 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016 Dec;91(12):1262-1271. doi: 10.1002/ajh.24592.
PubMed 27870387Srour SA, Devesa SS, Morton LM, Check DP, Curtis RE, Linet MS, Dores GM. Incidence and patient survival of myeloproliferative neoplasms and myelodysplastic/myeloproliferative neoplasms in the United States, 2001-12. Br J Haematol. 2016 Aug;174(3):382-96. doi: 10.1111/bjh.14061. Epub 2016 Apr 7.
PubMed 27061824Barbui T, Thiele J, Carobbio A, Passamonti F, Rumi E, Randi ML, Bertozzi I, Vannucchi AM, Gisslinger H, Gisslinger B, Finazzi G, Ruggeri M, Rodeghiero F, Rambaldi A, Gangat N, Tefferi A. Disease characteristics and clinical outcome in young adults with essential thrombocythemia versus early/prefibrotic primary myelofibrosis. Blood. 2012 Jul 19;120(3):569-71. doi: 10.1182/blood-2012-01-407981. Epub 2012 Jun 13.
PubMed 22700720Szuber N, Vallapureddy RR, Penna D, Lasho TL, Finke C, Hanson CA, Ketterling RP, Pardanani A, Gangat N, Tefferi A. Myeloproliferative neoplasms in the young: Mayo Clinic experience with 361 patients age 40 years or younger. Am J Hematol. 2018 Dec;93(12):1474-1484. doi: 10.1002/ajh.25270. Epub 2018 Sep 27.
PubMed 30157297Andrikovics H, Krahling T, Balassa K, Halm G, Bors A, Koszarska M, Batai A, Dolgos J, Csomor J, Egyed M, Sipos A, Remenyi P, Tordai A, Masszi T. Distinct clinical characteristics of myeloproliferative neoplasms with calreticulin mutations. Haematologica. 2014 Jul;99(7):1184-90. doi: 10.3324/haematol.2014.107482. Epub 2014 Jun 3.
PubMed 24895336Barbui T, Barosi G, Birgegard G, Cervantes F, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Hehlmann R, Hoffman R, Kiladjian JJ, Kroger N, Mesa R, McMullin MF, Pardanani A, Passamonti F, Vannucchi AM, Reiter A, Silver RT, Verstovsek S, Tefferi A; European LeukemiaNet. Philadelphia-negative classical myeloproliferative neoplasms: critical concepts and management recommendations from European LeukemiaNet. J Clin Oncol. 2011 Feb 20;29(6):761-70. doi: 10.1200/JCO.2010.31.8436. Epub 2011 Jan 4.
PubMed 21205761Tefferi A, Vardiman JW. Classification and diagnosis of myeloproliferative neoplasms: the 2008 World Health Organization criteria and point-of-care diagnostic algorithms. Leukemia. 2008 Jan;22(1):14-22. doi: 10.1038/sj.leu.2404955. Epub 2007 Sep 20.
PubMed 17882280Klampfl T, Gisslinger H, Harutyunyan AS, Nivarthi H, Rumi E, Milosevic JD, Them NC, Berg T, Gisslinger B, Pietra D, Chen D, Vladimer GI, Bagienski K, Milanesi C, Casetti IC, Sant'Antonio E, Ferretti V, Elena C, Schischlik F, Cleary C, Six M, Schalling M, Schonegger A, Bock C, Malcovati L, Pascutto C, Superti-Furga G, Cazzola M, Kralovics R. Somatic mutations of calreticulin in myeloproliferative neoplasms. N Engl J Med. 2013 Dec 19;369(25):2379-90. doi: 10.1056/NEJMoa1311347. Epub 2013 Dec 10.
PubMed 24325356Nangalia J, Massie CE, Baxter EJ, Nice FL, Gundem G, Wedge DC, Avezov E, Li J, Kollmann K, Kent DG, Aziz A, Godfrey AL, Hinton J, Martincorena I, Van Loo P, Jones AV, Guglielmelli P, Tarpey P, Harding HP, Fitzpatrick JD, Goudie CT, Ortmann CA, Loughran SJ, Raine K, Jones DR, Butler AP, Teague JW, O'Meara S, McLaren S, Bianchi M, Silber Y, Dimitropoulou D, Bloxham D, Mudie L, Maddison M, Robinson B, Keohane C, Maclean C, Hill K, Orchard K, Tauro S, Du MQ, Greaves M, Bowen D, Huntly BJP, Harrison CN, Cross NCP, Ron D, Vannucchi AM, Papaemmanuil E, Campbell PJ, Green AR. Somatic CALR mutations in myeloproliferative neoplasms with nonmutated JAK2. N Engl J Med. 2013 Dec 19;369(25):2391-2405. doi: 10.1056/NEJMoa1312542. Epub 2013 Dec 10.
PubMed 24325359
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients With Philadelphia Negative Myeloproliferative Neoplasms at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05401864
- Acronym / sponsor ID
- philadelphia negative MPNS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 2 Jun 2022 (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.
Classic Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs) are a family of clonal chronic hematologic malignancies that include. polycythemia vera (PV), essential thrombocythemia (ET), and primary. Myelofibrosis (MF) . The classic MPNs historically have predominantly been diagnosed in older adults, with a median age at diagnosis of 60-72 years . Adults less than 40 years of age make up a largely underrepresented and therefore less studied subset of patients constituting 2.2-6.6% of yearly MPN cases in population- based study. These estimates are lower than incidence rate among patients between 40 and 49 years of age (9.1-10%), and have remained largely unchanged over the past four decades . However, with increasing trends in MPN incidence consequent to increased diagnostic recognition, better pathobiologic understanding, and more frequent JAK2/CALR/MPL mutational testing and newly revised WHO diagnostic criteria, it is conceivable that MPNs may be diagnosed at a higher frequency, in the younger patients, over time.
Detailed description
Diagnosis of MPN according to the revised 2008 WHO criteria is based on a. combination of clinical, morphological, and molecular parameters ( Cardinal features of Philadelphia chromosome-negative MPN are increased red blood cell (RBC). production in PV, sustained thrombocytosis in ET, and bone marrow (BM) fibrosis in PMF. Molecular markers, such as JAK2 V617F, JAK2 exon 12, and MPL mutations, have increased our knowledge of the pathogenesis of MPNs as well as the accuracy of diagnosis. Furthermore, many recent studies have reported that the calreticulin mutation (mutation in exon 9 of CALR) is found in the majority of patients with MPN with non mutated JAK2 . There are many controversies with regard to the subjectivity and the lack of reproducibility of the histological criteria. And BM assessment is not always needed, especially in PV. However, histologic evaluation of the pathologic features of megakaryocytic, granulocytic, and erythroid series and cellularity is important in differentiating MPNs, especially ET and PMF . Sometimes, patients with occult MPN present with normal blood counts because of gastrointestinal bleeding and associated iron deficiency, splenomegaly, or simply because they are in an early stage of the disorder . In cases of clinically suspicious MPN, such as intra-abdominal thrombosis with normal blood counts, careful investigation is needed.
diagnostic criteria for myeloproliferative (World Health Organization) 2008. Polycythemia refers to an increase in the number of red blood cells in the body. The extra cell cause the blood to be thicker, and this, in turn, increases the risk of other health issues, such as blood clots.
Maior criteria including. Hemoglobin > 18.5 g/dL (men), > 16.5 g/dL (women) or Presence of JAK2 V617F or JAK2 exon 12 mutation Minor criteria: BM hypercellularity with trilineage myeloproliferation Subnormal serum erythropoitin. Endogenous erythroid colony formation in vitro.
Management of polycythemia: The most common treatment for polychythemia vera is having frequent blood withdrawals, using a needle in a vein (phlebotomy).
Drugs that reduce the number of red blood cells If phlebotomy alone doesn't help enough, your doctor may suggest medications that can reduce the number of red blood cells in your bloodstream. Examples include: Hydroxyruea (Droxia, Hydrea), Interferon alfa-2b (Intron A), Ruxolitinib (Jakafi), Busulfan (Busulfex, Myleran) .
Primary myelofibrosis (PMF) is a rare bone marrow disorder that is characterized by abnormalities in blood cell production (hematopoiesis) and scarring (formation of fibrous tissue) within the bone marrow. Bone marrow is the soft, spongy tissue that fills the center of most bones. Major criteria including. Megakaryocyte proliferation and atypiab, accompanied by either reticulin and/or collagen fibrosis, orc Not meeting WHO criteria for PV, CML, MDS, or other myeloid neoplasm Demonstration of JAK2 V617F or other clonal marker or no evidence of bone marrow fibrosis.
prognosis scoring was the international prognostic scoring system (IPSS). IPSS was first produced in 2009 and was designed for application at the time of diagnosis. This IPSS was the result of data from 1054 consecutively diagnosed patients with PMF from 1980 to 2007. 4 risk groups were identified, with median survivals ranging from 23 years (high-risk) to 11.3 months (low-risk). Abnormal cytogenetic findings did not appear to affect patient outcomes. IPSS included five risk factors: age >65 years, hemoglobin <10 g/dl, leukocyte count >25 x 109/L, circulating blasts ≥1% and constitutional symptoms. In 2010, DIPSS was adapted from IPSS, which allowed clinicians to use prognostic scoring at any time in the clinical course. Both IPSS and DIPSS (Dynamic IPSS) used the same five clinical risk factors to determine patient prognosis.
Management of mylofibrosis: Low-risk myelofibrosis may not require immediate treatment, while people with high-risk myelofibrosis may consider an aggressive treatment, such as bone marrow transplant. For intermediate-risk myelofibrosis, treatment is usually directed at managing symptoms. Immediate treatment may not be necessary Myelofibrosis treatment may not be necessary if you aren't experiencing symptoms. You might not need treatment right away if you don't have an enlarged spleen and you don't have anemia or your anemia is very mild. Rather than treatment, your doctor is likely to monitor your health closely through regular checkups Treatments for anemia: Blood transfusions, Androgen therapy, Thalidomide and related medications.
Treatments for an enlarged spleen: Chemotherapy, Targeted drug therapy, (splenectomy). If your spleen becomes so large, Radiation therapy. Bone marrow transplant.
Essential thrombocytosis (ET), or primary thrombocythemia, is a rare disorder in which the body produces too many platelets for unknown reasons. This can cause abnormal blood clotting or bleeding. Majorcriteria: Sustained platelet count > 450 × 109/LProliferation of megakaryocytes with enlarged, mature morphology Not meeting WHO criteria for PV, PMF, CML, MDS or other myeloid neoplasm Demonstration of JAK2 V617F or other clonal marker, or no evidence for reactive Thrombocytosis. Patients with low-risk ET are usually managed with low-dose aspirin, whereas treatment of high-risk ET is based on the use of cytoreductive therapy, with hydroxyurea as the drug of choice and IFN-α being reserved for young patients or pregnant women
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Philadelphia negative myloproliferative neoplasms at Assuit university hospital
Key inclusion criteria (1 listed)
- Patients with Philadelphia negative above 18yrs old who were attend at our unit over 2 years duration.
Key exclusion criteria (1 listed)
- All pt with Philadelphia positive and below 18.
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
characteristics data of philadilphia negative myloproleferative neoplasm
Time frame: 2 years
Characteristics data of philadilphia negative myloproleferative neoplasm admitted inassiut university hospital in 2years in single center experience this data including age .sex ipss score and management of MPN
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Background: PubMed 26182311Tefferi A, Pardanani A. Myeloproliferative Neoplasms: A Contemporary Review. JAMA Oncol. 2015 Apr;1(1):97-105. doi: 10.1001/jamaoncol.2015.89.
- Background: PubMed 27870387Tefferi A. Primary myelofibrosis: 2017 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016 Dec;91(12):1262-1271. doi: 10.1002/ajh.24592.
- Background: PubMed 27061824Srour SA, Devesa SS, Morton LM, Check DP, Curtis RE, Linet MS, Dores GM. Incidence and patient survival of myeloproliferative neoplasms and myelodysplastic/myeloproliferative neoplasms in the United States, 2001-12. Br J Haematol. 2016 Aug;174(3):382-96. doi: 10.1111/bjh.14061. Epub 2016 Apr 7.
- Background: PubMed 22700720Barbui T, Thiele J, Carobbio A, Passamonti F, Rumi E, Randi ML, Bertozzi I, Vannucchi AM, Gisslinger H, Gisslinger B, Finazzi G, Ruggeri M, Rodeghiero F, Rambaldi A, Gangat N, Tefferi A. Disease characteristics and clinical outcome in young adults with essential thrombocythemia versus early/prefibrotic primary myelofibrosis. Blood. 2012 Jul 19;120(3):569-71. doi: 10.1182/blood-2012-01-407981. Epub 2012 Jun 13.
- Background: PubMed 30157297Szuber N, Vallapureddy RR, Penna D, Lasho TL, Finke C, Hanson CA, Ketterling RP, Pardanani A, Gangat N, Tefferi A. Myeloproliferative neoplasms in the young: Mayo Clinic experience with 361 patients age 40 years or younger. Am J Hematol. 2018 Dec;93(12):1474-1484. doi: 10.1002/ajh.25270. Epub 2018 Sep 27.
- Background: PubMed 24895336Andrikovics H, Krahling T, Balassa K, Halm G, Bors A, Koszarska M, Batai A, Dolgos J, Csomor J, Egyed M, Sipos A, Remenyi P, Tordai A, Masszi T. Distinct clinical characteristics of myeloproliferative neoplasms with calreticulin mutations. Haematologica. 2014 Jul;99(7):1184-90. doi: 10.3324/haematol.2014.107482. Epub 2014 Jun 3.
- Background: PubMed 21205761Barbui T, Barosi G, Birgegard G, Cervantes F, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Hehlmann R, Hoffman R, Kiladjian JJ, Kroger N, Mesa R, McMullin MF, Pardanani A, Passamonti F, Vannucchi AM, Reiter A, Silver RT, Verstovsek S, Tefferi A; European LeukemiaNet. Philadelphia-negative classical myeloproliferative neoplasms: critical concepts and management recommendations from European LeukemiaNet. J Clin Oncol. 2011 Feb 20;29(6):761-70. doi: 10.1200/JCO.2010.31.8436. Epub 2011 Jan 4.
- Background: PubMed 17882280Tefferi A, Vardiman JW. Classification and diagnosis of myeloproliferative neoplasms: the 2008 World Health Organization criteria and point-of-care diagnostic algorithms. Leukemia. 2008 Jan;22(1):14-22. doi: 10.1038/sj.leu.2404955. Epub 2007 Sep 20.
- Background: PubMed 24325356Klampfl T, Gisslinger H, Harutyunyan AS, Nivarthi H, Rumi E, Milosevic JD, Them NC, Berg T, Gisslinger B, Pietra D, Chen D, Vladimer GI, Bagienski K, Milanesi C, Casetti IC, Sant'Antonio E, Ferretti V, Elena C, Schischlik F, Cleary C, Six M, Schalling M, Schonegger A, Bock C, Malcovati L, Pascutto C, Superti-Furga G, Cazzola M, Kralovics R. Somatic mutations of calreticulin in myeloproliferative neoplasms. N Engl J Med. 2013 Dec 19;369(25):2379-90. doi: 10.1056/NEJMoa1311347. Epub 2013 Dec 10.
- Background: PubMed 24325359Nangalia J, Massie CE, Baxter EJ, Nice FL, Gundem G, Wedge DC, Avezov E, Li J, Kollmann K, Kent DG, Aziz A, Godfrey AL, Hinton J, Martincorena I, Van Loo P, Jones AV, Guglielmelli P, Tarpey P, Harding HP, Fitzpatrick JD, Goudie CT, Ortmann CA, Loughran SJ, Raine K, Jones DR, Butler AP, Teague JW, O'Meara S, McLaren S, Bianchi M, Silber Y, Dimitropoulou D, Bloxham D, Mudie L, Maddison M, Robinson B, Keohane C, Maclean C, Hill K, Orchard K, Tauro S, Du MQ, Greaves M, Bowen D, Huntly BJP, Harrison CN, Cross NCP, Ron D, Vannucchi AM, Papaemmanuil E, Campbell PJ, Green AR. Somatic CALR mutations in myeloproliferative neoplasms with nonmutated JAK2. N Engl J Med. 2013 Dec 19;369(25):2391-2405. doi: 10.1056/NEJMoa1312542. Epub 2013 Dec 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Philadelphia Negative Myeloproliferative Neoplasms, run by Assiut University.
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 8 Jun 2022. 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?
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?
characteristics data of philadilphia negative myloproleferative neoplasm (time frame: 2 years). 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 NCT05401864, which also lists 10 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 8 Jun 2022.