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Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC

9 december 2021 uppdaterad av: Tang-Du Hospital

Utility of ctDNA In Predicting Whether Giving Adjuvant Chemotherapy In Patients With Stage IB-IIA Resected Non-small Cell Lung Cancer: A Prospective Cohort Study

This clinical trial aims to explore the minimal residual disease (MRD) status of early NSCLC after curative surgery and the clinical outcomes of adjuvant chemotherapy. Next-generation sequencing technique will be used to examine the circulating tumor DNA (ctDNA) from MRD of 150 postoperative patients with stage IB-IIA NSCLC who received adjuvant chemotherapy.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Minimal residual disease (MRD) refers to the small number of malignant cells that remain after curative treatments (curative intent surgical resection, radiotherapy, and/or chemotherapy). MRD is common in patients with blood cancer, and is known to be associated with recurrence and poor prognosis. Recent studies also reported that MRD-negative in postoperative solid tumors such as colorectal/colon cancer and breast cancer is associated with better survival outcomes. However, the clinical values of MRD monitoring for adjuvant therapy in postoperative NSCLC remain inadequate.

Circulating tumor DNA (ctDNA), a type of cell-free DNA, refers to the DNA fragments that are derived from tumor cells and circulate in the blood. Recently, next-generation sequencing (NGS) was successfully applied to monitor NPM1, RUNX1 and FLT3 mutations in multiple myeloma. Thus, NGS technique is a promising tool for sensitive MRD monitoring, which provides the ctDNA profiling from MRD, and then provides future decision-making treatment for postoperative NSCLC patients. Thus, this clinical study aims to monitor the ctDNA status of MRD, and to explore the clinical value of MRD monitoring in decision-making adjuvant therapy for patients with stage IB-IIA NSCLC after curative surgery.

A total of 150 patients with primary curable stage IB-IIA NSCLC will be recruited in this clinical trial. The following samples will be collected from each patient including 1) preoperative blood samples; 2) surgical tissue samples; 3) blood samples 3-7 days after surgery; 4) blood samples every 3-6 month during adjuvant chemotherapy; and 5) white blood control samples. In addition, demographic and tumor characteristics of the patients will be collected for subsequent analysis, including age, sex, tumor stage, pathological stage, disease couse time, PS score, etc. NGS will be used to analyze the whole exons of potential driver genes to obtain the MRD status. Statistical analyses will be performed to analyze the survival outcomes of MRD-positive and MRD-negative group and to explore the clinical value of MRD monitoring for adjuvant therapy in postoperative NSCLC.

Studietyp

Observationell

Inskrivning (Förväntat)

150

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Baqiao
      • Xi'an, Baqiao, Kina, 710038
        • Rekrytering
        • The Second Affiliated The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)
        • Kontakt:
          • Yunfeng Ni
          • Telefonnummer: +86 13772088014
        • Huvudutredare:
          • Tao Jiang, MD
        • Underutredare:
          • Yunfeng Ni, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patents with histologically confirmed primary NSCLC, stage IB-IIA, aged 18-70 years

Beskrivning

Inclusion Criteria:

  • Patients aged between 18 and 70 years
  • Histological diagnosis of primary NSCLC
  • Patients received curative surgery for primary NSCLC
  • Tumor stage IB-IIA after curative-intent surgical resection
  • ECOG score: 0-1
  • Participant is willing to use an acceptable form of contraception during the study.
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • The patient has received neoadjuvant therapy, including radiotherapy and chemotherapy, targeted therapy and immunotherapy
  • Patients are unwilling or unable to receive the curative-intent resection
  • Patients have or have had history of malignant tumor
  • Patients who suffer from severe uncontrolled disease that require systemic treatment or considered unsuitable for participating this trial due to other reasons by the investigator
  • Patients with severe gastrointestinal dysfunction, cardiac dysfunction, interstitial lung disease, etc.
  • Laboratory test results showed inadequate bone marrow or organ function
  • Blood transfusion during or within 2 weeks before the surgery
  • History of alcohol abuse or drug overdose
  • Pregnant or breastfeeding women
  • Patients who are currently or have participated in any other anti-tumor clinical trials
  • Inadequate baseline data, such as preoperative and postoperative blood samples (Lack of 2 consecutive blood test or a total of 3 blood samples), surgical tumor tissues, and ctDNA test.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
MRD-positive Cohort
ctDNA positivity in pretreatment and posttreatment plasma samples was defined by accessing the presence of one or more mutations identified in match tumor samples. A mutation was considered present when at least one consensus read contained the mutation and passed the local polishing pipeline. The MRD positive cohort was randomly divided into two groups, one group for interventional treatment and the other group for observation.
Läkemedel: Adjuvants, Pharmaceutic
Patients with stage IB-IIA NSCLC after curative surgery were treated with adjuvant chemotherapy. The blood samples of the patients before and after adjuvant chemotherapy will be collected to examine the MRD status
Andra namn:
  • adjuvant kemoterapi
MRD-negative Cohort
ctDNA negative in pretreatment and posttreatment plasma samples was defined by accessing the presence of no mutation identified in match tumor samples. According to the clinical prognostic characteristics of the MRD negative group, the clinician decides to observe or treat.
Läkemedel: Adjuvants, Pharmaceutic
Patients with stage IB-IIA NSCLC after curative surgery were treated with adjuvant chemotherapy. The blood samples of the patients before and after adjuvant chemotherapy will be collected to examine the MRD status
Andra namn:
  • adjuvant kemoterapi

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
3-year DFS rate
Tidsram: 3 years

DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

Locoregional recurrence or distant metastases as determined by an independent central radiology assessment.

Occurrence of the second primary (same or other) cancer as determined by an independent central radiology assessment.

Death from any cause. Loss to follow-up is censored.
3 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ctDNA status
Tidsram: Through study completion, up to 5 years
Change of Circulating tumor DNA (ctDNA) status (every 3 months)
Through study completion, up to 5 years
TEAE
Tidsram: Through study completion, up to 3 years
Occurrence of treatment emergent adverse event (TEAE)
Through study completion, up to 3 years
IMP
Tidsram: Through study completion, up to 3 years
Occurrence of dose reduction and discontinuation of IMP due to a TEAE
Through study completion, up to 3 years
Overall survival
Tidsram: 3 years and 5 years
Follow-up of the patients will be conducted to analyze 3-year and 5-year overall survival
3 years and 5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tang-Du Hospital

Utredare

  • Huvudutredare: Tao Jiang, Department of Thoracic Surgery, Tangdu Hospital, the Fourth Military Medical University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 september 2021

Primärt slutförande (Förväntat)

1 september 2023

Avslutad studie (Förväntat)

1 december 2024

Studieregistreringsdatum

Först inskickad

5 november 2021

Först inskickad som uppfyllde QC-kriterierna

9 december 2021

Första postat (Faktisk)

22 december 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 december 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 december 2021

Senast verifierad

1 december 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 777436

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

IPD-planbeskrivning

The trial is recruiting patients

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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