Correlation Analysis of Gene Characteristics of Malignant Tumors With Prognosis
28 de maio de 2026 atualizado por: Nanfang Hospital, Southern Medical University
This study is a single-center observational investigation aimed at systematically exploring the key molecular features influencing the prognosis of malignant tumors by integrating multidimensional clinical information with multi-omics molecular data.
The goal is to provide a critical scientific basis for constructing precise prognostic prediction models, identifying potential therapeutic targets, and optimizing clinical treatment strategies.
The study plans to consecutively enroll adult patients with histologically confirmed malignant tumors who received antitumor therapy at our hospital between January 2017 and December 2025.
Clinical data (including demographic characteristics, tumor pathology information, treatment histories, and survival follow-up data) will be systematically collected from electronic medical records.
Additionally, tumor tissue or blood samples will be obtained from the patients for sequencing, staining, ELISA, drug sensitivity testing, and flow cytometry analysis to comprehensively characterize the genomic features, immune microenvironment, and cellular heterogeneity of the tumors.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
500
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Wei Wang Wang
- Número de telefone: 02061642135
- E-mail: 29262574@qq.com
Locais de estudo
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Guangdong
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Guangzhou, Guangdong, China
- Recrutamento
- Nanfang Hospital, Southern Medical University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients with pathologically confirmed malignant tumors.
Descrição
Inclusion Criteria:
- Voluntarily sign the informed consent form.
- Treated at Nanfang Hospital, Southern Medical University between January 2017 and December 2025.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Availability of surplus routinely discarded clinical tumor tissue samples (biopsy specimens or pathological sections) or blood samples for assays such as sequencing, staining, ELISA, drug sensitivity testing, and flow cytometry.
Exclusion Criteria:Patients deemed by the investigator to be unsuitable for participation in this study.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Grupo de Imunoterapia
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Patients receiving immunotherapies such as immune checkpoint inhibitors.
Immunotherapy can be administered as first-line or subsequent treatment, or as part of combination therapy, integrated with modalities such as surgery, chemotherapy, radiotherapy, and targeted therapy.
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Radiotherapy Group
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Patients for whom radiotherapy is the primary or a significant component of their treatment.
Radiotherapy may be administered with curative, adjuvant, or palliative intent, and can be given alone or in combination with surgery, chemotherapy, targeted therapy, immunotherapy, etc.
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Surgery Group
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Patients undergoing curative tumor resection as their primary treatment modality.
Surgery may be performed with or without neoadjuvant/adjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall Survival (OS)
Prazo: From date of treatment initiation until date of death or last follow-up, assessed up to 5 years.
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The time from the start of treatment to death from any cause.
Patients who are alive at the last follow-up are censored.
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From date of treatment initiation until date of death or last follow-up, assessed up to 5 years.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS)
Prazo: From date of treatment initiation until date of progression or death, assessed up to 5 years.
|
The time from the start of treatment to the first documented disease progression (per RECIST criteria) or death from any cause, whichever occurs first.
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From date of treatment initiation until date of progression or death, assessed up to 5 years.
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Pathological Complete Response (pCR)
Prazo: At the time of surgery following neoadjuvant treatment, typically within 4-6 weeks after completion of therapy.
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The absence of residual invasive cancer in the resected tumor specimen and lymph nodes after neoadjuvant therapy, as determined by histopathological evaluation.
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At the time of surgery following neoadjuvant treatment, typically within 4-6 weeks after completion of therapy.
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Major Pathologic Response (MRP)
Prazo: At the time of surgery following neoadjuvant treatment, typically within 4-6 weeks after completion of therapy.
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The presence of ≤10% residual viable tumor cells in the resected tumor specimen after neoadjuvant therapy, assessed by pathological examination.
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At the time of surgery following neoadjuvant treatment, typically within 4-6 weeks after completion of therapy.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7. Epub 2019 Apr 4.
- Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, Harris PL, Haserlat SM, Supko JG, Haluska FG, Louis DN, Christiani DC, Settleman J, Haber DA. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med. 2004 May 20;350(21):2129-39. doi: 10.1056/NEJMoa040938. Epub 2004 Apr 29.
- Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8.
- Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D'Angelo SP, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019 Feb;51(2):202-206. doi: 10.1038/s41588-018-0312-8. Epub 2019 Jan 14.
- Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14.
- Reig M, Sanduzzi-Zamparelli M, Forner A, Rimola J, Ferrer-Fabrega J, Burrel M, Garcia-Criado A, Diaz A, Llarch N, Iserte G, Molla M, Kelley RK, Galle PR, Mazzaferro V, Salem R, Sangro B, Singal AG, Vogel A, Yanagihara TK, Ayuso C, Torres F, Bruix J. BCLC strategy for prognosis prediction and treatment recommendations: The 2026 update. J Hepatol. 2026 Mar;84(3):631-654. doi: 10.1016/j.jhep.2025.10.020. Epub 2025 Oct 27.
- Rami-Porta R, Nishimura KK, Giroux DJ, Detterbeck F, Cardillo G, Edwards JG, Fong KM, Giuliani M, Huang J, Kernstine KH Sr, Marom EM, Nicholson AG, Van Schil PE, Travis WD, Tsao MS, Watanabe SI, Rusch VW, Asamura H; Members of the IASLC Staging and Prognostic Factors Committee and of the Advisory Boards, and Participating Institutions. The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groups in the Forthcoming (Ninth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2024 Jul;19(7):1007-1027. doi: 10.1016/j.jtho.2024.02.011. Epub 2024 Mar 4.
- GBD 2023 Cancer Collaborators. The global, regional, and national burden of cancer, 1990-2023, with forecasts to 2050: a systematic analysis for the Global Burden of Disease Study 2023. Lancet. 2025 Oct 11;406(10512):1565-1586. doi: 10.1016/S0140-6736(25)01635-6. Epub 2025 Sep 24.
- Prior IA, Lewis PD, Mattos C. A comprehensive survey of Ras mutations in cancer. Cancer Res. 2012 May 15;72(10):2457-67. doi: 10.1158/0008-5472.CAN-11-2612.
- Marchio C, Annaratone L, Marques A, Casorzo L, Berrino E, Sapino A. Evolving concepts in HER2 evaluation in breast cancer: Heterogeneity, HER2-low carcinomas and beyond. Semin Cancer Biol. 2021 Jul;72:123-135. doi: 10.1016/j.semcancer.2020.02.016. Epub 2020 Feb 26.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
29 de maio de 2026
Conclusão Primária (Estimado)
30 de janeiro de 2027
Conclusão do estudo (Estimado)
30 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
28 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de maio de 2026
Primeira postagem (Real)
3 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NFEC-2026-090
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
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