NCT05401864

Brief 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) . 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

May 30, 2022

Last Update Submit

June 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Philadelphia negative myloproliferative neoplasms at Assuit university hospital

You may qualify if:

  • \- Patients with Philadelphia negative above 18yrs old who were attend at our unit over 2 years duration.

You may not qualify if:

  • All pt with Philadelphia positive and below 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Tefferi A, Pardanani A. Myeloproliferative Neoplasms: A Contemporary Review. JAMA Oncol. 2015 Apr;1(1):97-105. doi: 10.1001/jamaoncol.2015.89.

    PMID: 26182311BACKGROUND
  • Tefferi 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.

    PMID: 27870387BACKGROUND
  • Srour 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.

    PMID: 27061824BACKGROUND
  • Barbui 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.

    PMID: 22700720BACKGROUND
  • Szuber 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.

    PMID: 30157297BACKGROUND
  • Andrikovics 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.

    PMID: 24895336BACKGROUND
  • Barbui 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.

    PMID: 21205761BACKGROUND
  • Tefferi 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.

    PMID: 17882280BACKGROUND
  • Klampfl 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.

    PMID: 24325356BACKGROUND
  • Nangalia 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.

    PMID: 24325359BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Hematology Department , Principal Investigator

Study Record Dates

First Submitted

May 30, 2022

First Posted

June 2, 2022

Study Start

June 1, 2022

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

June 8, 2022

Record last verified: 2022-06