Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT06140992
Status:
RECRUITING
Last Update Posted:
2025-06-18
First Post:
2023-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PaCIFiC-CUP Classifies Cancer of Unknown Primary
Sponsor:
Organization:
Raw JSON
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Electronic address: clinicalguidelines@esmo.org. Cancer of unknown primary: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Mar;34(3):228-246. doi: 10.1016/j.annonc.2022.11.013. Epub 2022 Dec 20. No abstract available.'}, {'pmid': '24937670', 'type': 'BACKGROUND', 'citation': 'Paziewska A, Dabrowska M, Goryca K, Antoniewicz A, Dobruch J, Mikula M, Jarosz D, Zapala L, Borowka A, Ostrowski J. DNA methylation status is more reliable than gene expression at detecting cancer in prostate biopsy. Br J Cancer. 2014 Aug 12;111(4):781-9. doi: 10.1038/bjc.2014.337. Epub 2014 Jun 17.'}, {'pmid': '32879405', 'type': 'BACKGROUND', 'citation': 'Wehmas LC, Hester SD, Wood CE. Direct formalin fixation induces widespread transcriptomic effects in archival tissue samples. Sci Rep. 2020 Sep 2;10(1):14497. doi: 10.1038/s41598-020-71521-w.'}, {'pmid': '29539639', 'type': 'BACKGROUND', 'citation': 'Capper D, Jones DTW, Sill M, Hovestadt V, Schrimpf D, Sturm D, Koelsche C, Sahm F, Chavez L, Reuss DE, Kratz A, Wefers AK, Huang K, Pajtler KW, Schweizer L, Stichel D, Olar A, Engel NW, Lindenberg K, Harter PN, Braczynski AK, Plate KH, Dohmen H, Garvalov BK, Coras R, Holsken A, Hewer E, Bewerunge-Hudler M, Schick M, Fischer R, Beschorner R, Schittenhelm J, Staszewski O, Wani K, Varlet P, Pages M, Temming P, Lohmann D, Selt F, Witt H, Milde T, Witt O, Aronica E, Giangaspero F, Rushing E, Scheurlen W, Geisenberger C, Rodriguez FJ, Becker A, Preusser M, Haberler C, Bjerkvig R, Cryan J, Farrell M, Deckert M, Hench J, Frank S, Serrano J, Kannan K, Tsirigos A, Bruck W, Hofer S, Brehmer S, Seiz-Rosenhagen M, Hanggi D, Hans V, Rozsnoki S, Hansford JR, Kohlhof P, Kristensen BW, Lechner M, Lopes B, Mawrin C, Ketter R, Kulozik A, Khatib Z, Heppner F, Koch A, Jouvet A, Keohane C, Muhleisen H, Mueller W, Pohl U, Prinz M, Benner A, Zapatka M, Gottardo NG, Driever PH, Kramm CM, Muller HL, Rutkowski S, von Hoff K, Fruhwald MC, Gnekow A, Fleischhack G, Tippelt S, Calaminus G, Monoranu CM, Perry A, Jones C, Jacques TS, Radlwimmer B, Gessi M, Pietsch T, Schramm J, Schackert G, Westphal M, Reifenberger G, Wesseling P, Weller M, Collins VP, Blumcke I, Bendszus M, Debus J, Huang A, Jabado N, Northcott PA, Paulus W, Gajjar A, Robinson GW, Taylor MD, Jaunmuktane Z, Ryzhova M, Platten M, Unterberg A, Wick W, Karajannis MA, Mittelbronn M, Acker T, Hartmann C, Aldape K, Schuller U, Buslei R, Lichter P, Kool M, Herold-Mende C, Ellison DW, Hasselblatt M, Snuderl M, Brandner S, Korshunov A, von Deimling A, Pfister SM. DNA methylation-based classification of central nervous system tumours. Nature. 2018 Mar 22;555(7697):469-474. doi: 10.1038/nature26000. Epub 2018 Mar 14.'}, {'pmid': '33479225', 'type': 'BACKGROUND', 'citation': 'Koelsche C, Schrimpf D, Stichel D, Sill M, Sahm F, Reuss DE, Blattner M, Worst B, Heilig CE, Beck K, Horak P, Kreutzfeldt S, Paff E, Stark S, Johann P, Selt F, Ecker J, Sturm D, Pajtler KW, Reinhardt A, Wefers AK, Sievers P, Ebrahimi A, Suwala A, Fernandez-Klett F, Casalini B, Korshunov A, Hovestadt V, Kommoss FKF, Kriegsmann M, Schick M, Bewerunge-Hudler M, Milde T, Witt O, Kulozik AE, Kool M, Romero-Perez L, Grunewald TGP, Kirchner T, Wick W, Platten M, Unterberg A, Uhl M, Abdollahi A, Debus J, Lehner B, Thomas C, Hasselblatt M, Paulus W, Hartmann C, Staszewski O, Prinz M, Hench J, Frank S, Versleijen-Jonkers YMH, Weidema ME, Mentzel T, Griewank K, de Alava E, Martin JD, Gastearena MAI, Chang KT, Low SYY, Cuevas-Bourdier A, Mittelbronn M, Mynarek M, Rutkowski S, Schuller U, Mautner VF, Schittenhelm J, Serrano J, Snuderl M, Buttner R, Klingebiel T, Buslei R, Gessler M, Wesseling P, Dinjens WNM, Brandner S, Jaunmuktane Z, Lyskjaer I, Schirmacher P, Stenzinger A, Brors B, Glimm H, Heining C, Tirado OM, Sainz-Jaspeado M, Mora J, Alonso J, Del Muro XG, Moran S, Esteller M, Benhamida JK, Ladanyi M, Wardelmann E, Antonescu C, Flanagan A, Dirksen U, Hohenberger P, Baumhoer D, Hartmann W, Vokuhl C, Flucke U, Petersen I, Mechtersheimer G, Capper D, Jones DTW, Frohling S, Pfister SM, von Deimling A. Sarcoma classification by DNA methylation profiling. Nat Commun. 2021 Jan 21;12(1):498. doi: 10.1038/s41467-020-20603-4.'}, {'pmid': '23670100', 'type': 'BACKGROUND', 'citation': 'Hovestadt V, Remke M, Kool M, Pietsch T, Northcott PA, Fischer R, Cavalli FM, Ramaswamy V, Zapatka M, Reifenberger G, Rutkowski S, Schick M, Bewerunge-Hudler M, Korshunov A, Lichter P, Taylor MD, Pfister SM, Jones DT. Robust molecular subgrouping and copy-number profiling of medulloblastoma from small amounts of archival tumour material using high-density DNA methylation arrays. Acta Neuropathol. 2013 Jun;125(6):913-6. doi: 10.1007/s00401-013-1126-5. Epub 2013 May 14. No abstract available.'}, {'pmid': '25965575', 'type': 'BACKGROUND', 'citation': 'Pajtler KW, Witt H, Sill M, Jones DT, Hovestadt V, Kratochwil F, Wani K, Tatevossian R, Punchihewa C, Johann P, Reimand J, Warnatz HJ, Ryzhova M, Mack S, Ramaswamy V, Capper D, Schweizer L, Sieber L, Wittmann A, Huang Z, van Sluis P, Volckmann R, Koster J, Versteeg R, Fults D, Toledano H, Avigad S, Hoffman LM, Donson AM, Foreman N, Hewer E, Zitterbart K, Gilbert M, Armstrong TS, Gupta N, Allen JC, Karajannis MA, Zagzag D, Hasselblatt M, Kulozik AE, Witt O, Collins VP, von Hoff K, Rutkowski S, Pietsch T, Bader G, Yaspo ML, von Deimling A, Lichter P, Taylor MD, Gilbertson R, Ellison DW, Aldape K, Korshunov A, Kool M, Pfister SM. Molecular Classification of Ependymal Tumors across All CNS Compartments, Histopathological Grades, and Age Groups. Cancer Cell. 2015 May 11;27(5):728-43. doi: 10.1016/j.ccell.2015.04.002.'}, {'pmid': '26919435', 'type': 'BACKGROUND', 'citation': 'Sturm D, Orr BA, Toprak UH, Hovestadt V, Jones DTW, Capper D, Sill M, Buchhalter I, Northcott PA, Leis I, Ryzhova M, Koelsche C, Pfaff E, Allen SJ, Balasubramanian G, Worst BC, Pajtler KW, Brabetz S, Johann PD, Sahm F, Reimand J, Mackay A, Carvalho DM, Remke M, Phillips JJ, Perry A, Cowdrey C, Drissi R, Fouladi M, Giangaspero F, Lastowska M, Grajkowska W, Scheurlen W, Pietsch T, Hagel C, Gojo J, Lotsch D, Berger W, Slavc I, Haberler C, Jouvet A, Holm S, Hofer S, Prinz M, Keohane C, Fried I, Mawrin C, Scheie D, Mobley BC, Schniederjan MJ, Santi M, Buccoliero AM, Dahiya S, Kramm CM, von Bueren AO, von Hoff K, Rutkowski S, Herold-Mende C, Fruhwald MC, Milde T, Hasselblatt M, Wesseling P, Rossler J, Schuller U, Ebinger M, Schittenhelm J, Frank S, Grobholz R, Vajtai I, Hans V, Schneppenheim R, Zitterbart K, Collins VP, Aronica E, Varlet P, Puget S, Dufour C, Grill J, Figarella-Branger D, Wolter M, Schuhmann MU, Shalaby T, Grotzer M, van Meter T, Monoranu CM, Felsberg J, Reifenberger G, Snuderl M, Forrester LA, Koster J, Versteeg R, Volckmann R, van Sluis P, Wolf S, Mikkelsen T, Gajjar A, Aldape K, Moore AS, Taylor MD, Jones C, Jabado N, Karajannis MA, Eils R, Schlesner M, Lichter P, von Deimling A, Pfister SM, Ellison DW, Korshunov A, Kool M. New Brain Tumor Entities Emerge from Molecular Classification of CNS-PNETs. Cell. 2016 Feb 25;164(5):1060-1072. doi: 10.1016/j.cell.2016.01.015.'}, {'pmid': '32817081', 'type': 'BACKGROUND', 'citation': 'Pisanic TR 2nd, Wang Y, Sun H, Considine M, Li L, Wang TH, Wang TL, Shih IM. Methylomic Landscapes of Ovarian Cancer Precursor Lesions. Clin Cancer Res. 2020 Dec 1;26(23):6310-6320. doi: 10.1158/1078-0432.CCR-20-0270. Epub 2020 Aug 17.'}, {'pmid': '35307512', 'type': 'BACKGROUND', 'citation': 'Muller D, Gyorffy B. DNA methylation-based diagnostic, prognostic, and predictive biomarkers in colorectal cancer. Biochim Biophys Acta Rev Cancer. 2022 May;1877(3):188722. doi: 10.1016/j.bbcan.2022.188722. Epub 2022 Mar 17.'}, {'pmid': '33506766', 'type': 'BACKGROUND', 'citation': 'Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.'}, {'pmid': '30261643', 'type': 'BACKGROUND', 'citation': 'Nunes SP, Moreira-Barbosa C, Salta S, Palma de Sousa S, Pousa I, Oliveira J, Soares M, Rego L, Dias T, Rodrigues J, Antunes L, Henrique R, Jeronimo C. Cell-Free DNA Methylation of Selected Genes Allows for Early Detection of the Major Cancers in Women. Cancers (Basel). 2018 Sep 26;10(10):357. doi: 10.3390/cancers10100357.'}, {'pmid': '27575023', 'type': 'BACKGROUND', 'citation': 'Moran S, Martinez-Cardus A, Sayols S, Musulen E, Balana C, Estival-Gonzalez A, Moutinho C, Heyn H, Diaz-Lagares A, de Moura MC, Stella GM, Comoglio PM, Ruiz-Miro M, Matias-Guiu X, Pazo-Cid R, Anton A, Lopez-Lopez R, Soler G, Longo F, Guerra I, Fernandez S, Assenov Y, Plass C, Morales R, Carles J, Bowtell D, Mileshkin L, Sia D, Tothill R, Tabernero J, Llovet JM, Esteller M. Epigenetic profiling to classify cancer of unknown primary: a multicentre, retrospective analysis. Lancet Oncol. 2016 Oct;17(10):1386-1395. doi: 10.1016/S1470-2045(16)30297-2. Epub 2016 Aug 27.'}, {'pmid': '37089814', 'type': 'BACKGROUND', 'citation': 'Zhang Z, Lu Y, Vosoughi S, Levy JJ, Christensen BC, Salas LA. HiTAIC: hierarchical tumor artificial intelligence classifier traces tissue of origin and tumor type in primary and metastasized tumors using DNA methylation. NAR Cancer. 2023 Apr 19;5(2):zcad017. doi: 10.1093/narcan/zcad017. eCollection 2023 Jun.'}, {'pmid': '23641043', 'type': 'BACKGROUND', 'citation': 'Greco FA, Lennington WJ, Spigel DR, Hainsworth JD. Molecular profiling diagnosis in unknown primary cancer: accuracy and ability to complement standard pathology. J Natl Cancer Inst. 2013 Jun 5;105(11):782-90. doi: 10.1093/jnci/djt099. Epub 2013 May 2.'}, {'pmid': '31932775', 'type': 'BACKGROUND', 'citation': 'Maros ME, Capper D, Jones DTW, Hovestadt V, von Deimling A, Pfister SM, Benner A, Zucknick M, Sill M. Machine learning workflows to estimate class probabilities for precision cancer diagnostics on DNA methylation microarray data. Nat Protoc. 2020 Feb;15(2):479-512. doi: 10.1038/s41596-019-0251-6. Epub 2020 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to initially utilize machine learning on pan-cancer DNA methylation data from public databases to construct a DNA methylation classification model (PaCIFiC-CUP, pan-cancer integrated fingerprinting classifier of CUP) for diagnosing various types of cancer, particularly the primary site of cancer of unknown primary. The goal is to achieve diagnosis of cancer pathology type by analyzing the DNA methylation patterns of cancer specimens, thereby guiding subsequent precision treatment for cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients diagnosed with CUP who meet the inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient specimens were obtained from the Sun Yat-sen University Cancer Center and affiliated cooperating centers, with written consent from the patients authorizing the use of the specimens for research purposes.\n2. Following standard assessments (medical history, physical examination, complete blood count, biochemistry, computed tomography scans of the neck, chest, abdomen, and pelvis, targeted evaluations of all symptomatic areas, pathology, and immunohistochemistry), the diagnosis was determined as a primary site unknown tumor (including adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, sarcoma, etc).\n3. The diagnosis was confirmed at the participating institution and the patient had received systemic therapy.\n4. Complete clinical, pathological, and follow-up data for the patients can be obtained.\n5. ECOG performance status score: 0-2 points.\n\nExclusion Criteria:\n\n1. Pregnant or lactating female patients.\n2. Tumor tissue sample size is too small (tumor tissue accounts for \\<70% in the biopsy or slice tissue).\n3. Organ transplant or history of non-autologous (allogeneic) bone marrow or stem cell transplantation.\n4. History of previous tumors, with the current condition being a recurrent tumor.\n5. Hematological malignancies (excluding lymphoma).\n6. Other diseases that may severely impact patient survival, such as severe cardiovascular or cerebrovascular diseases, sepsis, severe trauma or burns, etc.'}, 'identificationModule': {'nctId': 'NCT06140992', 'briefTitle': 'PaCIFiC-CUP Classifies Cancer of Unknown Primary', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'PaCIFiC-CUP：Pan-Cancer Integrated Fingerprinting Classifier for Identifying the Origin of Cancer of Unknown Primary: A Multi-Center Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'PaCIFiC-CUP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Site-Specific Therapy Group', 'description': 'These patients with cancer of unknown primary received site-specific therapy that matched the particular site predicted by the DNA methylation classifier.'}, {'label': 'Empirical Therapy Group', 'description': "These patients with cancer of unknown primary received empirical therapy that didn't match the particular site predicted by the DNA methylation classifier."}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiyang Zhang', 'role': 'CONTACT', 'email': 'zhangyy@sysucc.org.cn', 'phone': '+8615652797092'}], 'facility': 'Sun Yat-sen university cancer center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yiyang Zhang', 'role': 'CONTACT', 'email': 'zhangyy@sysucc.org.cn', 'phone': '+8615652797092'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'Anhui Provincial Cancer Hospital', 'class': 'OTHER'}, {'name': "Dongguan People's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'Ganzhou Cancer Hospital', 'class': 'UNKNOWN'}, {'name': 'Guangzhou Chest Hospital.', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Jinan University', 'class': 'OTHER'}, {'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}, {'name': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiao-Peng Tian', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}