Neoplasms

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Communicable Diseases

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Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Sexually Transmitted Diseases, Viral

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Disease Attributes

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Skin Diseases, Viral

Skin Diseases, Infectious

Vaginal Cancer

All Drugs and Chemicals

Vaccines

Jikai Zhang

Yebin Yu

Quanyou Liu

To access the immune persistence of Chinese women aged 9-45 years after receiving quadrivalent HPV vaccine with the immunization schedule of 0, 2 and 6 months.

Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine

Evaluating the Immune Persistence of Recombination Quadrivalent HPV Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

Shanghai Bovax Biotechnology Co., Ltd.

Subjects aged 9-14 years, received 2 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 6-month schedule.

Subjects aged 9-19 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule.

Subjects aged 20-26 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule.

Subjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule.

2-doses Group among 9-14 years

Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

3-doses Group among 9-19 years

3-doses Group among 20-26 years

Ting Huang

Ji Zhang

This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years

This is a singel-center study (protocol 4-HPV-3002) in which women are planned to receive q-HPV vaccine. Study participation will last approximately 60 months and involves a total of nine or eleven scheduled visits.

This study will also assess whether the immunogenicity of the q-HPV vaccine given 2-dose schedule in 9-14 year old girls is noninferior to that in young women, aged 20-26, receiving 3 doses, and 3 doses in 9-19 year old girls is noninferior to that in young women receiving 3 doses, while assessing the safety of this vaccine.

Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

Evaluating the Immunogenicity and Safety of Quadrivalent Human Papillomavirus Recombinant Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 26 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

Number of subjects receiving the whole schedule vaccination with antibody responses as assessed by GMT and SCR, change from baseline among the seronegative vaccine recipients at Month 8

TNumber of subjects, aged 9 to 14, receiving the 2-doses scheduled vaccination with antibody responses as assessed by GMT and SCR, change from baseline among the seronegative vaccine recipients at Month 12, 24, 36, 48 and 60

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.3°C or 37.5°C) and urticaria.

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA) , Live infant, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.

Chongqing Bovax Biopharmaceutical Co., Ltd.

The patient will receive Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x 5 fractions using arc therapy.

Whole pelvis radiation therapy will be delivered according to institutional standard of care.

SBRT is delivered with 5 fractions of 5.5-8 Gy prescribed to the high-risk CTV, with dose constraints identical to those for high dose rate, volume-directed brachytherapy. The patient will undergo arc therapy with a minimum of two arcs. On-line kV CBCT will be used to verify the isocenter prior to each arc delivery. Patients will be resimulated for SBRT boost planning.

Radiation Therapy

Loren Mell, MD

The purpose of this study is to find out whether patients with cervical cancer treated with about a new radiation technique called "stereotactic body radiotherapy (SBRT) have less stress and anxiety compared to standard brachytherapy radiation. With standard brachytherapy radiation, metal hardware is placed through the vagina and into the uterus, which can cause pain and discomfort. SBRT is a new radiation technique that is non-invasive and does not require the insertion of any metal hardware.

This is a Phase II, single-center, single-arm, study of Stereotactic Body Radiotherapy boost for stage IB-IVB cervical cancer.

The primary objective of the study is to test the hypothesis that stereotactic body radiation therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress compared to brachytherapy (historical control) according to the Impact of Event Scale-Revision (IES-R).

Study participants will be recruited within the UCSD Health System. For those patients under the clinical management of the recruiting investigator, the investigator will review the patient's medical records and determine if they would be a candidate for the study. The investigator will approach the subject and offer participation in the trial. If the patient chooses to participate, they will undergo pretreatment evaluations to determine if they are a good candidate to participate further in the study. Depending on when the patient last had these tests and procedures performed, some of them may not need to be repeated.

Upon confirmation of all eligibility criteria, the subject will be enrolled. Each enrolled subject will receive radiation therapy consisting of 30 to 35 treatments. The patient will first undergo Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks, followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x 5 fractions using arc therapy. Concurrent chemotherapy may be given with radiation therapy according to the discretion of the treating oncology team. No chemotherapy will be given during the SBRT phase of treatment. During radiation therapy, the patient will have a weekly physical exam, vital signs collected, evaluation for pain, and review any side effects.

Subjects will undergo a post treatment follow-up period after completion of their radiation therapy. During this follow-up period, subjects will return for a medical and history review with a complete physical examination, review of any side effects, evaluation for outcomes and toxicity, and evaluations for stress, anxiety, and pain.

Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB

Non-Invasive Cervical Cancer Radiotherapy: Phase II Clinical Trial of Stereotactic Body Radiotherapy Boost for Stage IB-IVB Cervical Cancer

To quantify treatment-related symptoms of post traumatic stress to determine if stereotactic body radiation therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress compared to brachytherapy (historical control) according to the Impact of Event Scale-Revision (IES-R).

To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity following SBRT.

To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30).

To measure health-related quality of life based on the cervical cancer module (CX24).

To quantify intrafraction cervical motion using cone beam computed tomography.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine	NCT05371353	HPV Infections Cervical Cancer... Vaginal Cancer Genital Wart CIN1 CIN2 CIN3		9 Years - 45 Years	Shanghai Bovax Biotechnology Co., Ltd.
Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years	NCT05027776	HPV Infections Cervical Cancer... Vaginal Cancer Genital Wart CIN1 CIN2 CIN3	2-doses Group a... 3-doses Group a... 3-doses Group a...	9 Years - 26 Years	Shanghai Bovax Biotechnology Co., Ltd.
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB	NCT03146039	Cervical Cancer Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Radiation Thera...	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for cervical cancer stage iia