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| Name | Class |
|---|---|
| Maria Sklodowska-Curie National Research Institute of Oncology | OTHER |
| Łukasiewicz Research Network | UNKNOWN |
| Wroclaw University of Environmental and Life Sciences | OTHER |
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Prospective, low intervention, open, single-center, non-commercial clinical trial to improve diagnostics in patients with histiocytosis by assessing the molecular profile of the tumor tissues, monitoring its presence in free-circulating DNA, and determining the efficacy of fluorodeoxyglucose (18F-FDG) in PET-CT imaging.
HISTIOGEN clinical study is part of the POLHISTIO project. The POLHISTIO project is a non-commercial clinical trial aimed at optimizing the diagnosis and treatment of juvenile patients with histiocytosis. The project objectives are defined as follows: 1) to estimate the nature and frequency of mutations in patients with histiocytosis in both tumor tissues and free-circulating DNA; 2) to compare molecular test results with clinical data; 3) to evaluate the diagnostic usefulness of the status of molecular analysis (MRD) as a prognostic factor compared with other recognized factors. As part of the HISTIOGEN protocol, an immortalized cell line will be derived to study the pathogenesis of the disease, drug sensitivity, and drug resistance mechanisms. The project is intended to include patients from all over Poland
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R1 low intervention arm | Other | Children of both sexes who meet all inclusion criteria and do not meet any exclusion criteria will be eligible for the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorodeoxyglucose (18F-FDG) | Drug | max 6 MGBq/kg, no more than 100 |
|
| Measure | Description | Time Frame |
|---|---|---|
| EFS - (event-free survival) | Event-free survival (EFS) was defined as the time interval from the date of diagnosis to the date of disease progression, recurrence, second malignancy, death or to date of last follow-up for patients without events. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS (Overall Survival) | Overall Survival (OS) was defined as the time interval from the date of diagnosis to the date of death or to last follow-up date. | 2 years |
| Molecular relapse (in ct DNA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katarzyna Maleszewska | Contact | +48 22 32 77 205 | klinika.onkologii@imid.med.pl |
| Name | Affiliation | Role |
|---|---|---|
| Anna Raciborska | Mother and Child Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mother and Child Institute | Recruiting | Warsaw | Mazovian | 01-211 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29720485 | Background | Abla O, Jacobsen E, Picarsic J, Krenova Z, Jaffe R, Emile JF, Durham BH, Braier J, Charlotte F, Donadieu J, Cohen-Aubart F, Rodriguez-Galindo C, Allen C, Whitlock JA, Weitzman S, McClain KL, Haroche J, Diamond EL. Consensus recommendations for the diagnosis and clinical management of Rosai-Dorfman-Destombes disease. Blood. 2018 Jun 28;131(26):2877-2890. doi: 10.1182/blood-2018-03-839753. Epub 2018 May 2. | |
| 31563277 |
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| ID | Term |
|---|---|
| D015614 | Histiocytosis |
| D006646 | Histiocytosis, Langerhans-Cell |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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Molecular relapse was defined as the time interval from the date of any mutation negativization to the date of positive results of any mutation
| 2 years |
| Background |
| Andersson D, Fagman H, Dalin MG, Stahlberg A. Circulating cell-free tumor DNA analysis in pediatric cancers. Mol Aspects Med. 2020 Apr;72:100819. doi: 10.1016/j.mam.2019.09.003. Epub 2019 Sep 25. |
| 20519626 | Background | Badalian-Very G, Vergilio JA, Degar BA, MacConaill LE, Brandner B, Calicchio ML, Kuo FC, Ligon AH, Stevenson KE, Kehoe SM, Garraway LA, Hahn WC, Meyerson M, Fleming MD, Rollins BJ. Recurrent BRAF mutations in Langerhans cell histiocytosis. Blood. 2010 Sep 16;116(11):1919-23. doi: 10.1182/blood-2010-04-279083. Epub 2010 Jun 2. |
| 15390280 | Background | Donadieu J, Piguet C, Bernard F, Barkaoui M, Ouache M, Bertrand Y, Ibrahim H, Emile JF, Hermine O, Tazi A, Genereau T, Thomas C. A new clinical score for disease activity in Langerhans cell histiocytosis. Pediatr Blood Cancer. 2004 Dec;43(7):770-6. doi: 10.1002/pbc.20160. |
| 16163136 | Background | Fanti S, Franchi R, Battista G, Monetti N, Canini R. PET and PET-CT. State of the art and future prospects. Radiol Med. 2005 Jul-Aug;110(1-2):1-15. English, Italian. |
| 32187362 | Background | Goyal G, Heaney ML, Collin M, Cohen-Aubart F, Vaglio A, Durham BH, Hershkovitz-Rokah O, Girschikofsky M, Jacobsen ED, Toyama K, Goodman AM, Hendrie P, Cao XX, Estrada-Veras JI, Shpilberg O, Abdo A, Kurokawa M, Dagna L, McClain KL, Mazor RD, Picarsic J, Janku F, Go RS, Haroche J, Diamond EL. Erdheim-Chester disease: consensus recommendations for evaluation, diagnosis, and treatment in the molecular era. Blood. 2020 May 28;135(22):1929-1945. doi: 10.1182/blood.2019003507. |
| 23109216 | Background | Haupt R, Minkov M, Astigarraga I, Schafer E, Nanduri V, Jubran R, Egeler RM, Janka G, Micic D, Rodriguez-Galindo C, Van Gool S, Visser J, Weitzman S, Donadieu J; Euro Histio Network. Langerhans cell histiocytosis (LCH): guidelines for diagnosis, clinical work-up, and treatment for patients till the age of 18 years. Pediatr Blood Cancer. 2013 Feb;60(2):175-84. doi: 10.1002/pbc.24367. Epub 2012 Oct 25. |
| 31672857 | Background | Heitzer E. Circulating Tumor DNA for Modern Cancer Management. Clin Chem. 2019 Oct 31:clinchem.2019.304774. doi: 10.1373/clinchem.2019.304774. Online ahead of print. No abstract available. |
| 31015311 | Background | Janku F, Diamond EL, Goodman AM, Raghavan VK, Barnes TG, Kato S, Abdel-Wahab O, Durham BH, Meric-Bernstam F, Kurzrock R. Molecular Profiling of Tumor Tissue and Plasma Cell-Free DNA from Patients with Non-Langerhans Cell Histiocytosis. Mol Cancer Ther. 2019 Jun;18(6):1149-1157. doi: 10.1158/1535-7163.MCT-18-1244. Epub 2019 Apr 23. |
| 25351656 | Background | Murakami I, Gogusev J, Jaubert F, Matsushita M, Hayashi K, Miura I, Tanaka T, Oka T, Yoshino T. Establishment of a Langerhans cell histiocytosis lesion cell line with dermal dendritic cell characteristics. Oncol Rep. 2015 Jan;33(1):171-8. doi: 10.3892/or.2014.3567. Epub 2014 Oct 24. |
| 32917181 | Background | Raciborska A, Bilska K, Weclawek-Tompol J, Gryniewicz-Kwiatkowska O, Hnatko-Kolacz M, Stefanowicz J, Pieczonka A, Jankowska K, Pierelejewski F, Ociepa T, Sobol-Milejska G, Muszynska-Roslan K, Michon O, Badowska W, Radwanska M, Drabko K. Clinical characteristics and outcome of pediatric patients diagnosed with Langerhans cell histiocytosis in pediatric hematology and oncology centers in Poland. BMC Cancer. 2020 Sep 11;20(1):874. doi: 10.1186/s12885-020-07366-3. |
| D012140 | Respiratory Tract Diseases |