Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Adenocarcinoma of Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients with EGFR mutation in plasma detected by droplet digital PCR could receive Gefitinib 250mg every day until disease progression.

jie wang, doctor

This study was proposed to validate the efficacy of gefitinib as first-line therapy in advanced lung adenocarcinoma with EGFR mutation determined by plasma cf-DNA.

Patients without enough tissue for EGFR mutation detection can also have opportunity to use EGFR-TKI as first line therapy. Meanwhile, this study was also proposed to explore the best intervention time of anti-resistant drugs (such as AZD 9291, a T790M inhibitor) through the quantitative and dynamic analysis of EGFR sensitive and resistant mutation in plasma cf-DNA during EGFR-TKI treatment process.

Blood Detection of EGFR Mutation For Iressa Treatment

Peking University Cancer Hospital & Institute

Chief of thoracic cancer department

Symptoms and General Pathology

Blood and Lymph Conditions

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Collection of peripheral blood and bone marrow samples will occur during routine care procedures. Collection of finger stick and saliva specimens will occur on the same day as the peripheral blood and bone marrow procedure, or during routine clinical procedures.

This study will use our droplet digital PCR (ddPCR) method to quantify and track peripheral blood plasma MAF in MDS and AML patients before, during and after chemotherapy treatment. Quantification of MAF from fingersticks and saliva samples will also be performed to determine feasibility of obtaining adequate circulating tumor DNA (ctDNA) for ddPCR. Results from this project will generate a non-invasive means to monitor cancer response and progression months before current clinical methods, and provide an opportunity to intervene before the patient relapses.

droplet digital PCR

Leylah Drusbosky, PhD

This study will use droplet digital PCR (ddPCR) method to quantify and track peripheral blood plasma mutant allele frequency (MAF) in MDS and AML patients before, during and after chemotherapy treatment. Quantification of MAF from fingersticks and saliva samples will also be performed to determine feasibility of obtaining adequate circulating tumor DNA (ctDNA) for ddPCR.

The greatest challenge in cancer is relapsed disease. Despite best available therapies, approximately 20% of acute myeloid leukemia (AML) patients and 80% of myelodysplastic syndrome (MDS) patients die of relapsed disease. Minimal residual disease (MRD) is the main predictor of refractory disease following chemotherapy. In AML and MDS patients, mutant allele frequency (MAF) associates with future occurrence of relapse. Current oncology practice relies on painful bone marrow biopsies and light microscopy to monitor disease progression, remission, and relapse. Because of the bias in disease sampling and low sensitivity testing, there is an urgent need for a higher sensitivity test to monitor the tumor burden in these patients. The Investigator developed a rapid and ultrahigh sensitivity method to detect cancer-associated mutant alleles. This study will use our droplet digital PCR (ddPCR) method to quantify and track peripheral blood plasma MAF in MDS and AML patients before, during and after chemotherapy treatment. Quantification of MAF from fingersticks and saliva samples will also be performed to determine feasibility of obtaining adequate circulating tumor DNA (ctDNA) for ddPCR. Results from this project will generate a non-invasive means to monitor cancer response and progression months before current clinical methods, and provide an opportunity to intervene before the patient relapses. Furthermore, establishing a quantitative method to measure cancer burden will empower clinical researchers to measure biological activity in phase II and III clinical trials of new therapeutic agents.

* venipuncture peripheral blood
* bone marrow
* finger stick peripheral blood
* saliva

iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML

Predicting Disease Relapse by Monitoring Circulating Cancer DNA After Chemotherapy in Patients With MDS and AML

To count the number of myeloid mutations with the use of a droplet digital PCR (ddPCR) method which will quantify and track peripheral blood plasma, finger stick blood sample, and saliva mutant allele frequency (MAF) in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) patients before, during and after chemotherapy treatment.

To count the number myeloid mutations in ctDNA through the collection of serial samples from AML and MDS patients to determine minimal residual disease (MRD) or relapse free survival.

To count the overall number of finger stick and saliva ctDNA MAF and compare it to the overall number of peripheral blood and bone marrow MAF.

University of Florida

Neoplasm, Residual

Recurrence

Disease Attributes

Neoplastic Processes

Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period

Digital Droplet PCR

A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse

This is a retrospective and multicenter clinical study.This study is indicated for patients with hematological malignancies who underwent allo-HSCT. It aims to evaluate the effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse. 192 patients will be enrolled. The clinical end points include cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall survival.

MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse

Measurable Residual Disease Monitoring by Digital Droplet PCR in the Early Period After Allogeneic Hematopoietic Stem Cell Transplantation to Predict Patients at High Risk of Relapse

The time from the date of transplantation to disease recurrence:

Disease recurrence, defined as one of the following:

Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.

The time from the date of treatment to the occurrence of any of the following:

1. Death from any cause
2. Disease recurrence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Blood Detection of EGFR Mutation For Iressa Treatment	NCT02282267	Lung Adenocarci...	Gefitinib	18 Years - 75 Years	Peking University Cancer Hospital & Institute
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML	NCT03138395	Acute Leukemia Myelodysplastic... AML MDS	droplet digital...	18 Years - 100 Years	University of Florida
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML	NCT03138395	Acute Leukemia Myelodysplastic... AML MDS	droplet digital...	18 Years - 100 Years	University of Florida
MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse	NCT06000306	Measurable Resi...	Digital Droplet...	12 Years - 70 Years	Zhejiang University
Blood Detection of EGFR Mutation For Iressa Treatment	NCT02282267	Lung Adenocarci...	Gefitinib	18 Years - 75 Years	Peking University Cancer Hospital & Institute
MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse	NCT06000306	Measurable Resi...	Digital Droplet...	12 Years - 70 Years	Zhejiang University
Blood Detection of EGFR Mutation For Iressa Treatment	NCT02282267	Lung Adenocarci...	Gefitinib	18 Years - 75 Years	Peking University Cancer Hospital & Institute

Spots Global Cancer Trial Database for droplet digital pcr