Correlation Analysis of Gene Characteristics of Malignant Tumors With Prognosis
28 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
500
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Wei Wang Wang
- Número de teléfono: 02061642135
- Correo electrónico: 29262574@qq.com
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana
- Reclutamiento
- Nanfang Hospital, Southern Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with pathologically confirmed malignant tumors.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Grupo de Inmunoterapia
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival (OS)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Progression-Free Survival (PFS)
Periodo de tiempo: From date of treatment initiation until date of progression or death, assessed up to 5 years.
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
29 de mayo de 2026
Finalización primaria (Estimado)
30 de enero de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
28 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
3 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NFEC-2026-090
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .