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A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer

NCT06039982NOT_YET_RECRUITINGOBSERVATIONAL

Summary

This study aims to develop a diagnostic nomogram based on clinical factors with the prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and surgical procedures.

Key Facts

Lead Sponsor

Fujian Cancer Hospital

Enrollment

100

Start Date

2023-11-01

Completion Date

2026-11-01

Study Type

OBSERVATIONAL

Official Title

Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients

Interventions

no intervention

Conditions

Cervix Carcinoma

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

Inclusion Criteria:

* Pathologically confirmed cervical cancer;
* FIGO2018 stage IB-IIA according to the result of physical examination and images;
* No preoperative treatment before surgery;
* Abdominal MRI is performed within three weeks before surgery. Blood routine, biochemistry, blood tumor markers and coagulation function were examined within 1 week before surgery.
* All patients undergo radical hysterectomy (RH) with bilateral pelvic lymphadenectomy or paraaortic lymph node dissection.

Exclusion Criteria:

* Accompanied with other tumors;
* Accompanied with chronic infectious and immune diseases;
* Incomplete clinical data.

Outcome Measures

Primary Outcomes

vaginal invasion

100 cervical cancer patients who underwent radical hysterectomy (RH) with bilateral pelvic lymphadenectomy were pathologically assessed for vaginal invasion. The primary outcome is vaginal invasion or no-vaginal invasion. Pathological vaginal invasion is defined as cervix tumor disruption of the vaginal wall.

Time frame: 7 days after surgery

Locations

Fujian Cancer Hospital, Fuzhou, China

Linked Papers

2020-07-06

Measurement of tumor size in early cervical cancer: an ever-evolving paradigm

The major tenets in accurately assessing tumor size in patients with early stage cervical cancer currently include physical examination, imaging studies, and pathologic evaluation. It is estimated that when comparing clinical stage based on physical examination and final pathology, the concordance diminishes as stage increases: 85.4%, 77.4%, 35.3%, and 20.5% for stage IB1, IB2, IIA, and IIB, respectively. Vaginal involvement and larger tumor diameter are considered the main causes of stage inaccuracy. When considering imaging studies, magnetic resonance imaging (MRI) provides the highest level of accuracy in the assessment of cervical tumor size. Its accuracy in determining tumor location within the cervix is approximately 91% and in predicting tumor size 93%. MRI imaging is also significantly more accurate in measuring tumor size, delineating cervical tumor boundaries, and local tumor extension when compared with computed tomography (CT) scan. When comparing with pelvic ultrasound, the accuracy of both imaging techniques (MRI and pelvic ultrasound) in the assessment of tumor size in small versus large tumors is comparable. Pertaining to pathology, the depth of invasion should be measured by convention from the nearest surface epithelium, which equates to tumor thickness. In the setting where tumor is found both in the conization and hysterectomy specimen, the horizontal extent should be measured by summing the maximum horizontal measurement in the different specimens and the depth of invasion measured as the maximum depth in either specimen. A new pattern-based classification for endocervical adenocarcinomas recommends the description of patterns of invasion for human papillomavirus (HPV)-related adenocarcinomas as this is associated with differing risks of lymph node involvement.

Linked Investigators

Florencia Noll

I am a Gynaecologic oncologist, serving as an assistant professor and Head of the Oncology Unit at Sanatorio Allende Cerro in Cordoba, Argentina. Board member of the International Gynecological Cancer Society (IGCS), Latin America and Caribbean representative. Additionally, I serve as a board member of the Argentine Association of Gynecologic Oncology and the Argentine Society of Surgery. I am also a member of the Global Expert Advisory Group on Ovarian Cancer, organized by the World Ovarian Cancer Coalition. I completed an Editorial fellowship with the International Journal of Gynecological Cancer (IGCS), and I am a member of the editorial team of The International Journal of Gynecological Cancer (IJGC) and part of their peer-reviewing team. My involvement extends to several international societies, including the International Gynecologic Cancer Society (IGCS) and the European Society of Gynecologic Oncology (ESGO), where I participate in committees and regularly attend the ECHO Virtual Tumor project board meetings. I served on the oversight committee for The Every Woman Study™: Low- and Middle-Income Edition, a project aiming to identify the challenges and opportunities to enhance survival and quality of life for women diagnosed with ovarian cancer in resource-limited settings. I have authored and co-authored over 20 scientific publications. My primary clinical and research interests lie in healthcare, disease prevention, and treatment strategies for gynecologic cancer patients. My goal is to foster and facilitate global research collaborations and the development of international protocols.

Gloria Salvo

Rene Pareja