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Shiitake

AHCC®capsules, 5 capsules \* 3 times per day, empty stomach (defined as one hour before meal or two hours after meal).

Simulation of AHCC®capsules, 5 capsules \* 3 times per day, empty stomach (defined as one hour before meal or two hours after meal).

AHCC®capsules, a standardized extract of cultured Lentinula edodes mycelia (ECLM) TID for 6 months after enrolment.

AHCC®capsules

TID for 6 months after enrolment. A compensation of AHCC®is provided to participant from control arm when HR-HPV positive at 6 months after enrolment.

Simulation of AHCC®capsules

Beihua Kong, MD. PhD.

This is a multi-centre, randomised, double blind, placebo-controlled study on female participants with diagnosis of high-risk human papillomavirus (HR-HPV) infection to evaluate the clearance capacity of AHCC®.

Worldwide, cervical cancer is the fourth most common malignancy in women and a major cause of morbidity and mortality. It accounts for nearly 10% of all cancers. The etiology of cervical cancer has been identified and confirmed associated with high risk-human papillomavirus (HR-HPV). When HR-HPV infections persist overtime, patients have an increased risk of developing cervical cancer The proprietary, a standardized extract of cultured Lentinula edodes mycelia (ECLM), AHCC®, was developed in Japan in 1992. Several studies have reported a variety of therapeutic effects, including antioxidant and anticancer activity and improvement of immune response.

As recently reported study on AHCC®, pre-clinical in vitro and in vivo evidence demonstrated its durable clearance of HR-HPV infections. The preliminary data from the two pilot studies suggested that AHCC® supplementation supports the host immune system for successful clearance of HR-HPV infections. A confirmatory phase II randomized, double-blinded, placebo-controlled study is about completion. The preliminary results of this phase II study confirmed data observed in pilot studies that AHCC® supplementation for at least 6 months is associated with a 60% successful elimination of HPV infections and confirmed IFN-β correlates with clearance of persistent HPV infections. The optimal duration of AHCC® supplementation required after the first negative result still needs more evaluation in future clinical studies.

Nevertheless, all above mentioned studies have included western participants solely. The aim of this study is to evaluate the clearance capacity of AHCC® on Chinese female participants with diagnosis of HR-HPV infection.

Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female

Evaluation of Efficacy of AHCC®for the Clearance of High Risk-HPV Infections in Chinese Female: A Multi-centre, Randomised, Double Blind and Placebo-controlled Study

The desensitised protocol and metadata will be publicly available after completion.

In this method, the cervical cells are immersed in a conserving liquid before being fixed on the slide, avoiding desiccation and reducing the quantity of obscuring material. Liquid cytology can be prepared by manual or automated methods, and various systems are commercially available. They are mostly used for cervical cancer screening but are also adapted for FNAC samples.

The Cobas human papillomavirus (HPV) test is NMPA-approved for cervical and endocervical samples collected in PreservCyt (ThinPrep) media. The Cobas HPV test detects DNA of the high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect DNA of HPV low-risk types (e.g., 6, 11, 42, 43, 44) since these are not associated with cervical cancer and its precursor lesions.

Human IFN-β (Interferon beta) ELISA Kit will be applied for this test. This kit was based on sandwich enzyme-linked immune-sorbent assay technology. Capture antibody was precoated onto 96-well plates. And the biotin conjugated antibody was used as detection antibodies. The standards, test samples and biotin conjugated detection antibody were added to the wells subsequently, and washed with wash buffer. HRP-Streptavidin was added and unbound conjugates were washed away with wash buffer. TMB substrates were used to visualize HRP enzymatic reaction. TMB was catalysed by HRP to produce a blue colour product that changed into yellow after adding acidic stop solution. The density of yellow is proportional to the target amount of sample captured in plate. Read the O.D. absorbance at 450nm in a microplate reader, and then the concentration of target can be calculated.

Qilu Hospital of Shandong University

Shandong University

Professor, PhD

Neoplasms

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Sending of a vaginal self-sampling kit at home

Sending of a vaginal self-sampling kit at home + a SMS reminder is sent if the woman do not (in 2 months) :

* perform a pap smear
* or send her vaginal self-sample to the laboratory
* or contact the screening center to inform to an exclusion reason

Sending of letter offering a vaginal self-sampling kit. Women can ask for this kit on line, on our website or by calling us.

If they do ask for the kit, one kit is sending to their home.

For these women, a SMS reminder is sent if the woman do not (in 2 months) :

* perform a pap smear
* or send her vaginal self-sample to the laboratory
* or contact the screening center to inform to an exclusion reason

Sending of SMS offering a vaginal self-sampling kit. Women can ask for this kit on line, on our website or by calling us.

If they do ask for the kit, one kit is sending to their home.

For these women, a SMS reminder is sent if the woman do not (in 2 months) :

* perform a pap smear
* or send her vaginal self-sample to the laboratory
* or contact the screening center to inform to an exclusion reason

Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.

When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Self-sampling kit sent at home

Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.

After 2 months without "return", a SMS reminder about the available self-sampling kit is sent to the woman. We call "return" :

* the receipt of the vaginal self-sample at the laboratory
* the performance of a pap smear
* Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Self-sampling kit sent at home + SMS reminder

Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (kit provided on request) or to perform a pap smear.

Women are invited to ask the kit online, on our website.

For the women who ask the kit, after 2 months without "return", a SMS reminder about the available self-sampling kit is sent to the woman. We call "return" :

* the receipt of the vaginal self-sample at the laboratory
* the performance of a pap smear
* Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Letter offering a self-sampling kit "on request"+ SMS reminder

Selected women receive a SMS inviting them to ask a vaginal self sampling kit to perform a sample at home and send it to a laboratory (kit provided on request).

Women are invited to ask the kit by answering "1" by SMS.

For the women who ask the kit, after 2 months without "return", a SMS reminder about the available self-sampling kit is sent to the woman. We call "return" :

* the receipt of the vaginal self-sample at the laboratory
* the performance of a pap smear
* Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

SMS offering a self-sampling kit "on request"+ SMS reminder

Julie BOYARD, MSc

Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system "available on request" of the kit and / or the addition of an SMS (Short Message Service) reminder.

Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer

Randomized Trial Evaluating Women's Behavior Not Participating in Cervical Cancer Screening Facing Three Strategies for Optimizing Home Sending by Post of Vaginal Self-sampling Kit

Complete cervical cancer screening is defined as one of the followings :

* perform a pap smear
* perform a vaginal self-sampling with negative HR-HPV test
* perform a vaginal self-sampling with noninterpretable HR-HPV test result followed by a control pap smear (nine-month extension to do the pap smear after the sending of the HPV result)
* perform a vaginal self-sampling with positive HR-HPV test result followed by a control pap smear (nine-month extension to do the pap smear after the sending of the HPV result)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female	NCT04633330	High Risk Human... Low Grade Squam...	AHCC®capsules Simulation of A...	30 Years - 50 Years	Shandong University
Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female	NCT04633330	High Risk Human... Low Grade Squam...	AHCC®capsules Simulation of A...	30 Years - 50 Years	Shandong University
Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer	NCT03856684	Cervical Cancer... Cervical Cancer	Self-sampling k... Self-sampling k... Letter offering... SMS offering a ...	30 Years - 66 Years	University Hospital, Tours

Spots Global Cancer Trial Database for high risk human papillomavirus infection