- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05185544
Combining Genomics and Imageomics to Predict the Sensitivity of Neoadjuvant Pemetrexed and Cisplatin Chemotherapy in Patients With Lung Adenocarcinoma
January 5, 2022 updated by: Shanghai Zhongshan Hospital
Combining genomics and imageomics to predict the sensitivity of neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma
Description
Inclusion Criteria:
- 1. Aged between 18 and 75 years;
- 2. Lung adenocarcinoma;
- 3. The patient is able to receive neoadjuvant pemetrexed and cisplatin chemotherapy
- 4 .The patient is able to understand and comply with the study and has provided written informed consent.
Exclusion Criteria:
- 1. Patients with a history of lung surgery;
- 2. Postoperative pathology showed non-primary lung cancer;
- 3. Patients with a history of other tumors;
- 4. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
- 5. Unable to cooperate with the researchers because of dementia or cognitive decline
- 6. Other situations that are not in conformity with the standards and requirements of this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma
|
neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Tumor Regression Grade
Time Frame: 1-2 Weeks after enrollment (after Surgery)
|
1-2 Weeks after enrollment (after Surgery)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 1, 2022
Primary Completion (ANTICIPATED)
December 31, 2024
Study Completion (ANTICIPATED)
December 31, 2024
Study Registration Dates
First Submitted
December 18, 2021
First Submitted That Met QC Criteria
January 5, 2022
First Posted (ACTUAL)
January 11, 2022
Study Record Updates
Last Update Posted (ACTUAL)
January 11, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Hypersensitivity
- Adenocarcinoma
- Adenocarcinoma of Lung
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Cisplatin
- Pemetrexed
Other Study ID Numbers
- B2021-Zhan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.