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CIMAvax-EGF-Platelets-Adults- Lung Cancer
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3 August 2018 - 4:37pm
by Gladys
21 December 2020 - 11:28am
by lazara
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03
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2020
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12
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21
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Revision of 21 December 2020 - 11:28am:
CIMAvax-EGF-Platelets-Adults- Lung Cancer
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Evaluation of the behavior of platelets count, EGF serum concentrations and the levels of lymphocytes subpopulations expression associated with the patient's immune status as possible biomarkers of effectiveness of CIMAvax-EGF vaccine.
Secondary indentifying numbers:
FL-EC-020
Issuing authority of the secondary identifying numbers:
Center of Molecular Immunology (CIM)
Primary sponsor:
Center of Molecular Immunology (CIM)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Center of Molecular Immunology Cuban Ministry of Public Health (MINSAP)
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Ramon
Midle name:
Alberto
Last name:
Ortiz Carrodeguas
Medical Specialty :
Medical Doctor, first degree specialist in Oncology
Affiliation:
“Celestino Hernandez Robau” Hospital
Postal address:
Calle Cuba No. 569 entre Hospital y Alejandro Oms
City:
Santa Clara
Country:
Cuba
Zip Code:
50100
Telephone:
+53-042279442
+53-042271202
Email address:
ramonoc@infomed.sld.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Research ethics committees:
“Celestino Hernandez Robau” Hospital, April 12, 2017
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Recruiting
Date of first enrollment:
12/12/2017
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Advanced non small cell lung cancer
Health condition(s) code:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Health condition keyword:
NSCLC
Intervention(s):
Group CIMAvax-EGF (experimental): CIMAvax-EGF therapeutic vaccine, 2.4 mg by intramuscular route. The first 4 administrations will be every 14 days (induction stage) and, the rest of vaccines will administer every 28 days (maintenance stage) until the patient's clinical conditions allow. Prior to the first dose of the vaccine, immunomodulatory dose of cyclophosphamide (200 mg / m2, intramuscular route) will be administered.
Intervention code:
Immunotherapy, Active
Epidermal Growth Factor
Injections, Intramuscular
Intervention keyword:
CIMAvax-EGF
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Overall Survival: (Time from recruitment until death from any cause). Measurement time: 24 months
Key secondary outcomes:
1. Platelets (Platelets count). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment. 2. EGF serum concentration (Concentration of EGF in serum). Measurement time: At diagnosis, 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment. 3. Immune status of the patient (Percent and absolute value of T CD4+, T CD8+CD28- cells and TCD4/CD8 index, T regulators cells). Measurement time: 4 or 6 weeks after first line of chemotherapy and Months 3, 6, 9, 12, 15 and, 18 of treatment
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
18 years
Maximum age:
None
Inclusion criteria:
1. Patients of any sex and age similar or more than 18 years. 2. Patients that complete the diagnostic criteria. 3. Patients included in another clinical trial in which the therapeutic vaccine CIMAvax-EGF® is administered, or that they don't receive products in investigation and be managed follow up the Cuban Guide of treatment of patient with lung cancer 2016 version. 4. Patient that have signed the informed consent for the investigation. 5. Patient with performan status (ECOG) state from 0 at 3
Exclusion criteria:
1. Patient in fertile age that are not using an appropriate (intra-uterine devices, hormonal contraceptives, barrier methods or bond of trumpets) method of contraception. For the males (vasectomy, use of preservatives) while the treatment lasts 2. Pregnant, lactating or puerperal patients.
Type of population:
Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
N/A: single arm study
Masking:
Open
Control group:
Uncontrolled
Study design:
Single group
Phase:
N/A
Target sample size:
Patients to recruit in 18 months
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Geidy
Last Name:
Lorenzo Monteagudo
Specialty:
BSc. in Phamaceutical Sciences
Affiliation:
Center of Molecular Immunology
Postal Address:
Calle 216 Esquina 15, Atabey, Playa
City:
Havana
Country:
Cuba
Zip Code:
ZP 16040, Box 11600
Telephone:
+53-72717933
Email :
geydi@cim.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Danay
Last Name:
Hernandez Saavedra
Specialty:
First Degree Specialist in Immunology and Comprehensive General Medicine.
Affiliation:
Center of Molecular Immunology
Postal Address:
Calle 216 Esquina 15, Atabey, Playa.
City:
Havana
Country:
Cuba
Zip Code:
ZP 16040, Box 11600
Telephone:
+53-72717933
Email :
danay@cim.sld.cu
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000284
Date of Registration in Primary Registry:
03/08/2018
Record Verification Date:
2020/12/21
Next update date:
2021/12/21
Link to the spanish version:
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