Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cervical carcinoma (cervical cancer) is one of the major public health problems in the world; in Mexico it is the second leading cause of death in women. Almost all cases of cervical cancer are caused by the human papilloma virus (HPV). It is a very common virus that can be passed on by sexual contact. It usually takes many years to develop. Before the cancer actually develops, the cells of the cervix often show changes known as cervical intraepithelial neoplasia (CIN). Patients with CIN1 cells are unlikely to develop cancer and the abnormal cells will often disappear without treatment. However, they can also progress to CIN2 or CIN3, at which point, the risk of developing cervical cancer increases. Removing the cells at these stages is usually recommended. Some 50% of adolescents and young adults can be infected with HPV within the first few years of starting a sex life. 90-95% of infections are resolved thanks to the immune system. However, in certain cases some infected women become long-term infected (viral persistence) and suffer from chronic cervical inflammation, which increases the risk of cervical intraepithelial neoplasia and cancer. It is, therefore, very important to provide timely treatment for women with precancerous lesions (CIN), including the use of immunotherapies that enable the proper functioning of the immune system against viral persistence. Dialyzable leukocyte extract (DLE) can activate the immune response against infections or neoplasias. The main objective of this work was to document the effect of DLE immunotherapy on the immune response of patients with cervical lesions.

Who can participate?
Women diagnosed with CIN1.

What does the study involve?
First of all, participants undergo a medical history, assessment of clinical symptoms, cervical cytology, colposcopy and cervical biopsy. They are then randomly allocated to one of two groups. Those in group 1 are given DLE for one month. Those in group 2 are given a placebo (dummy treatment) for one month. After the months treatment is complete, each participant undergoes another assessment of their clinical symptoms, a colposcopy and a cervical biopsy.

What are the possible benefits and risks of participating?
Possible benefits to participating in this study include almost total remission of the clinical symptoms particularly those associated with cervicitis (inflammation of the cervix) and abdominal pain, remission of cervical lesions and free treatment.

Where is the study run from?
The National Polytechnic Institute, Clinic of Gynecology and Obstetrics, Hospital General de Milpa Alta, Center for Research and Advanced Studies and Laboratory Farmainmune (Mexico City, Mexico)

When is the study starting and how long is it expected to run for?
January 2013 to December 2013

Who is funding the study?
National Council of Science and Technology, Mexico

Who is the main contact?
Dr Guillermo Perez Ishiwara

Trial website

Contact information



Primary contact

Dr Guillermo Perez Ishiwara


Contact details

Escuela Nacional de Medicina y Homeopatía-IPN
239 Guillermo Massieu Helguera Street
La Escalera
Mexico City
+52 (01) 5729 6300 Ext. 55534.

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The dialyzable leukocyte extract activates cervical innate immunity in HPV-infected patients with CIN 1


Study hypothesis

If the dialyzable leukocyte extract (DLE) has an anti-inflammatory effect, the DLE treatment of HPV infected patients with preneoplasic lesions would regulate the cervical immune response, modifying the clinical and histopathological signs of the disease.

Ethics approval

Ethics Committee of the National School of Medicine and Homeopathy from National Polytechnic Institute (Mexico), 11/01/2015, ref: 0152013

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Low-grade cervical intraepithelial neoplasia (CIN-1)


A total of 54 Mexican women patients with cervical cytological diagnosis of CIN 1 were included in this study. After signing the consent form, patients were evaluated by clinical signs and symptoms. Then, colposcopy and biopsy were taken to confirm the Intraepithelial Low-Grade Lesion (CIN 1). Patients were randomly divided into two groups: placebo group and DLE-treatment group. Each group was treated in a double blind random way using 3 units of placebo or DLE per week, during one month. Then, patients were clinically evaluated and explored again by colposcopy. Cervical samples were taking for both, histopathological and immuno-histochemical assays. HPV genotyping were done from biopsy samples obtained before treatment.

Intervention type



Drug names

Primary outcome measures

1. The colposcopical characteristics of cervical lesions using the iodine test, qualitatively measuring the cervical localization and extension of the lesions
2. Evaluation of clinic signs and symptoms considering the Mexican NOM-014-SSA2-1994 for the prevention, detection, diagnosis, control and treatment of Cu CA

Measured before and after one month of treatment.

Secondary outcome measures

1. Histopathological characterization of biopsies lesions
2. Immunohistochemical evaluation of immunological markers related to innate immune response

Measured before and after one month of treatment.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Women between 20 and 60 years old with cytological CIN 1 diagnosis.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Women under 20 and over 60 years old
3. Diabetic
4. With autoimmune or infectious diseases
5. Patients with cervicitis under treatment
6. Diagnosed with cervical cancer in situ or invasive
7. With pre-malignant CIN III lesions whose biopsy shows positive margins
8. With pre-malignant lesions of cervical cancer that have been treated with invasive methods

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

National Polytechnic Institute (Instituto Politécnico Nacional)
Guillermo Massieu H. 239 Colonia La Escalera Gustavo A. Madero
Mexico City

Trial participating centre

Clinic of Gynecology and Obstetrics
Carlota Armero 5 B -20 Colonia CTM Culhuacan Delegacion Coyoacán
Mexico City

Trial participating centre

Hospital General de Milpa Alta
Blvd. José López Portillo 386 Colonia Santa Cruz Milpa Alta
Mexico City

Trial participating centre

Center for Research and Advanced Studies
Department of Genetics and Molecular Biology Av. Instituto Politécnico Nacional 2508 Colonia San Pedro Zacatenco
Mexico City

Trial participating centre

Laboratory Farmainmune
Naranjos 129 Colonia Petrolera Delegacion Azacapotzalco
Mexico City

Sponsor information


National School of Medicine and Homeopathy from National Polytechnic Institute (Mexico).

Sponsor details

Escuela Nacional de Medicina y Homeopatía-IPN
239 Guillermo Massieu Helguera Street
La Escalera
Mexico City
+52 (01) 5729 6300 Ext. 55534.

Sponsor type

Research organisation



Funder type


Funder name

Consejo Nacional de Ciencia y Tecnología

Alternative name(s)

National Council of Science and Technology, Mexico, CONACYT

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government



Results and Publications

Publication and dissemination plan

The relevance of this work is to report the immunological and histopathological findings related to the reduction of cervical lesions as well as the remission of inflammation due the administration of DLE. We plan to publish it as soon as possible in the Journal of Immunology Research.

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/10/2016: Internal review