Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Anna Myriam Perrone, MD

Anna Myriam Perrone

Pierandrea De IAco

High grade serous ovarian cancer represents the gynecological malignancy with the highest incidence of mortality. Decision-making tools are currently limited to the use of standard imaging modalities and analysis of serum biomarkers, such as CA 125, which often have low specificity and sensitivity. Recently, a growing research interest has been aimed at so-called circulating microRNAs (miRNAs). Indeed, it has been observed that miRNAs are abundantly present in all biological fluids and play the key role of messengers in intercellular communication. Cancer cells have a rapid turnover which results in a continuous release of nucleic acids and vesicles derived from the tumor itself, such as the tumor cells themselves that separate from the tumor mass to enter the bloodstream. Given their important role as modulators of gene expression, in order to preserve their integrity, miRNAs are encapsulated in specific vesicles, in order to prevent their degradation by the enzymes present in biological fluids. In this context, the chance of monitoring the expression levels of specific miRNAs represents a very interesting option both for an early diagnosis and for monitoring the clinical response to pharmacological treatment. Currently, there are no non-invasive approaches to monitor the clinical outcome in real time, while the identification of circulating biomarkers would allow prompt intervention, possibly modifying the pharmacological management in case of progression.

miRNAs in High Grade Serous Ovarian Cancer

Analysis of Circulating miRNAs as Potential Biomarkers of Diagnosis and Prognosis in High Grade Serous Ovarian Cancer

Evaluation of miRNA expression in longitudinal blood samples collected during every follow-up

Correlation between miRNAs deregulation and clinico-pathological and molecular data

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Symptoms and General Pathology

Uterine Cervical Neoplasms

Neoplasm Metastasis

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Positive occult lymph node metastasis pathology

David F Cantú-deLeón, MD, PhD

Persistent infections with high-risk subtypes of the human papillomavirus (HPV) are recognized as the etiological factor for developing cervical cancer. The aim od this study was to identify a miRNA profile in patients with early-stage cervical cancer with positive lymph node metastasis treated. Formalin-fixed paraffin-embedded (FFPE) tissue samples of patients with a diagnosis of early-stage cervical cancer treated by radical hysterectomy with lymphadenectomy were collected.

Cervical carcinoma (CC) is one of the most common cancers in women from countries with emerging economies; in Mexico, CC has the second highest incidence and mortality rate. Several studies have demonstrated that the most important prognostic factor is lymph node metastasis in early-stage CC patients prior to radical hysterectomy (RH) with bilateral pelvic lymphadenectomy (BPL), in which positive lymph node metastasis decreasing overall survival (OS) from 80% to 53% at 5 years.

MicroRNAs (miRNAs) are single-strand RNAs comprising approximately 21-23 nucleotides. miRNAs regulate gene expression through the inhibition of posttranscriptional events and, in some cases, induce the degradation of their target messenger RNA. In cancer, miRNAs can function as both oncogenes and/or as tumor suppressor genes depending on the function of their target genes.

Formalin-fixed paraffin-embedded (FFPE) tissue blocks from CC patients diagnosed between January 2006 and December 2013 at the Department of Oncologic Gynecology of the National Cancer Institute (Mexico City) were analyzed with the intention of selecting those with a confirmed histopathological diagnosis of stages IB1 or IIA1 CC treated with RH and BPL. Total RNA was extracted from 5 (10-µm) sections for selected tissues.For the clinical correlation analysis, the samples were divided into 2 groups: 1 with positive occult lymph node metastasis pathology and 1 without lymph node metastasis pathology. For both groups, patients were matched for age, tumor size and presence of lymphovascular permeation.

The identification of global miRNA profiles was performed using GeneChip miRNA 3.0 Array (Affymetrix, Cat. 902018) following the manufacturer's instructions. the microarray was hybridized and washed using the Affymetrix Fluidics Station 450 and scanned with the Affymetrix GeneChip Scanner 3000. After processing the images, the raw data were processed. To obtain the miRNA profile, the processed samples were divided into 2 groups, samples with lymph node metastasis and samples without lymph node metastasis. Differentially expressed miRNAs were identified using a cutoff value of p \<0.01 and a fold change (FC) of 1.5. miRNAs that met these criteria were classified as over-expressed or under-expressed.

Formalin-fixed paraffin-embedded tissue blocks.

microRNA Profile in Early-stage Cervical Cancer

microRNA Profile Associated With Positive Lymph Node Metastasis in Early-stage Cervical Cancer

Identify a subset of miRNAs with prognostic value associated with early-stage CC patients treated with RH and BPL with positive lymph node metastasis.

National Institute of Cancerología

Chief of clinical trials department

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy

All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy ± hormonal therapy

All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only.

To identify a panel of circulating miRNA markers which could help identify those breast cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy, and indeed serve as an overall prognostic factor and stratify patients into risk categories which would further guide their management. Similarly, the investigators aim to identify a panel of circulating miRNA markers which could monitor patient's response to chemotherapy and hormonal therapies. Ideally a suitable panel of markers would show significant changes in expression level in good-responders whilst little or no change would be observed in miRNA expression in non-responders.

Primary Objectives:

1. To identify a panel of miRNAs, detectable in the circulation, which are altered in breast cancer patients
2. To identify specific combinations of miRNAs ('signatures') which associate with breast cancer intrinsic subtypes, and thereby could aid in prognostication and treatment planning on an individual patient basis.

Secondary Objective:

1. To determine if systemic miRNA analysis can be used as a biomarker for monitoring response to chemotherapy, in the neoadjuvant setting and in patients who present with breast cancer recurrence and are treated with upfront chemotherapy and/or hormonal therapy.

   This is a prospective cohort studies, involving three study cohorts:

   Cohort 1: All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy.

   Cohort 2: All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy +/- hormonal therapy.

   Cohort 3: All breast cancer patients who present with metastatic disease who are commencing hormonal therapy only.

   Blood Sample

   Blood Sampling - Cohort 1:

   - Blood sample 1: at presentation before commencing neoadjuvant treatment.

   - Blood sample 2: midway through their chemotherapy treatment (after 2nd cycle if they are enrolled in a 4 cycle regimen, or after 4th cycle if they are prescribed an 8 week regimen).

   - Blood sample 3: post-chemotherapy (before surgery as applicable).

   - Blood sample 4: 2 to 4 weeks after surgery, or 2 to 4 weeks post 3rd blood sampling if patients do not undergo surgery.

   - Blood sample 5: once during follow-up of 12 to 18 months after surgery or 12 to 18 months post 3rd blood sampling if patients do not undergo surgery.

   Blood Sampling - Cohort 2:

   - Pre-treatment blood sample: at presentation before commencing treatment.

   - On study blood samples: taken at monthly (± 1 week) intervals for a period of 6 months from date of pre-treatment blood sample, despite whether the patient is on treatment or completed treatment.

   On study blood sample 1: 1 month (± 1 week) from date of pre-treatment blood sample

   On study blood sample 2: 2 months (± 1 week) from date of pre- treatment blood sample

   On study blood sample 3: 3 months (± 1 week) from date of pre-treatment blood sample

   On study blood sample 4: 4 months (± 1 week) from date of pre-treatment blood sample

   On study blood sample 5: 5 months (± 1 week) from date of pre-treatment blood sample

   On study blood sample 6: 6 months (± 1 week) from date of pre-treatment blood sample

   - End of study blood sample: once during follow-up of 12 to 18 months from date of pre-treatment blood sample or at the time of disease progression.

   Blood Sampling - Cohort 3:

   - Pre-treatment blood sample: at presentation before commencing treatment.

   - On study blood samples: taken at the following time points despite whether the patient is on treatment or completed treatment.

   On study blood sample 1: 3 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 2: 6 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 3: 12 months (± 2 weeks) from date of pre-treatment blood sample

   - End of study blood sample: 18 months (± 2 weeks) from date of pre-treatment blood sample or at the time of disease progression.

   Blood samples will be processed for miRNA analysis, which involves:

1. Lysis using Trizol 2. RNA isolation 3. Assessing concentration and integrity of RNA using Nanodrop spectrophotometry 4. cDNA synthesis (using miRNA specific stem loop primers) 5. PCR amplification and relative quantification (using miRNA specific probes)

Circulating miRNAs.

Novel Breast Cancer Biomarkers and Their Use for Guiding and Monitoring Response to Chemotherapy

For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses.

For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1." For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses.

For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1."

Standard bio markers of response include serum CEA and Ca15-3 levels

Other existing clinicopathological parameters include: ER, PR and HER2 status, stage of disease,histological grade and size of the tumour, and the Nottingham Prognostic Index.

Study title	NCT ID	Conditions	Eligibility	Organization
miRNAs in High Grade Serous Ovarian Cancer	NCT05146505	High Grade Sero...	-	IRCCS Azienda Ospedaliero-Universitaria di Bologna
microRNA Profile in Early-stage Cervical Cancer	NCT04087785	Cervical Cancer	18 Years -	National Institute of Cancerología
Circulating miRNAs.	NCT01722851	Breast Cancer Newly Diagnosed... Recurrent Breas...	18 Years -	Cancer Trials Ireland
miRNAs in High Grade Serous Ovarian Cancer	NCT05146505	High Grade Sero...	-	IRCCS Azienda Ospedaliero-Universitaria di Bologna

Spots Global Cancer Trial Database for mirnas

Every month we try and update this database with for mirnas cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mirnas

Every month we try and update this database with for mirnas cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mirnas cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.