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Recruiting NCT07622667

Correlation Analysis of Gene Characteristics of Malignant Tumors With Prognosis

— Observational Malignant Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immunotherapy Therapy, Radiation Therapy, Radical surgery.
Who it may be relevant to
Registry conditions: Malignant Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Immunotherapy Therapy
    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.
  • Radiation Radiation Therapy
    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.
  • Procedure Radical surgery
    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.

Primary outcome measures

  • Overall Survival (OS) [Time frame: From date of treatment initiation until date of death or last follow-up, assessed up to 5 years.]
Secondary outcome measures (3)
  • Progression-Free Survival (PFS) [Time frame: From date of treatment initiation until date of progression or death, assessed up to 5 years.]
  • Pathological Complete Response (pCR) [Time frame: At the time of surgery following neoadjuvant treatment, typically within 4-6 weeks after completion of therapy.]
  • Major Pathologic Response (MRP) [Time frame: At the time of surgery following neoadjuvant treatment, typically within 4-6 weeks after completion of therapy.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Nanfang Hospital, Southern Medical University — Guangzhou

Publications

  • 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. PMID 22589270
  • 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. PMID 15118073
  • 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. PMID 32112814
  • 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, Pardo PMID 28596308
  • 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, PMID 30643254
  • 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. Lan PMID 30955977
  • 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, v PMID 24529560
  • 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. PMID 41151697

Identifiers

NCT: NCT07622667 · NFEC-2026-090

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗