Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

SLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging

quantitative reverse transcription polymerase chain reaction (qRT-PCR) cytokeratin-19 detection in specimen (sentinel lymph node)

RD-100i, OSNA

Ondřej Topolčan, Prof. MUDr.

Zdeněk Novotný, Doc.MUDr.

The aim of the study is to compare one-step nucleic acid amplification method (OSNA) with histological ultrastaging examination in the sentinel lymph node assessment in patients with endometrial cancer.

The molecular biologic method OSNA is a modern way of metastatic spread detection in lymphatic nodes using quantitative reverse transcription polymerase chain reaction. Cytokeratin 19 (CK 19) was selected based on previous studies as the optimal mRNA marker (detected by OSNA).

The intraoperative identification and rapid assessment of sentinel lymph nodes by OSNA could help to improve the standards of care in endometrial cancer patients.

Method:

After the sentinel lymph node detection (ICG, 99m Tc or Bleu Patente) and sentinel node/nodes removal is performed, the node/nodes is/are cut in 2-mm slices parallel to short axis of the node. The odd-numbered blocks will be examined by the OSNA method and the even-numbered blocks will be examined by conventional histopathological methods including immunohistochemistry.

Statistical analysis to identify differences will be performed subsequently.

Samples of the tissue homogenate will be retained and may be used for further testing.

SLNM in Endometrial Cancer Combined With OSNA

Sentinel Lymph Node Mapping in Endometrial Cancer Patients Combined With One-step Nucleic Acid Amplification (OSNA)

Number of CK 19 copies will be assessed: 250-5000 micrometastasis, more than 5000 copies macrometastasis. This result will be compared to histological ultrastaging examination.

University Hospital Pilsen

Charles University, Czech Republic

MUDr.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.

Vicente Peg, MD

Isabel Rubio, MD, PhD

Martin Espinosa-Bravo, MD, PhD

This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.

The aim of the present study is to assess the intraoperative positive SLN total tumor load (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN metastasis in patients with clinically node-negative early-stage breast cancer.

Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer

Estimate the negative predictive value of the technique OSNA for the cutoff point that maximizes (tentatively, 10,000 to 15,000 copies / uL) of axillary lymph node involvement in breast cancer early N0.

ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs

Probability that OSNA in sentinel lymph nodes (SLN) is positive given that there is involvement of non-sentinel lymph nodes (NSLN)

Probability that OSNA in SLN is negative because there is no involvement of NSLN

Likelihood ratio of positive and negative results

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SLNM in Endometrial Cancer Combined With OSNA	NCT02826291	Endometrial Can...	RD-100i, OSNA	18 Years -	Charles University, Czech Republic
Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer	NCT01669265	Breast Cancer		-	SOLTI Breast Cancer Research Group
SLNM in Endometrial Cancer Combined With OSNA	NCT02826291	Endometrial Can...	RD-100i, OSNA	18 Years -	Charles University, Czech Republic

Spots Global Cancer Trial Database for osna

Every month we try and update this database with for osna 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 osna

Every month we try and update this database with for osna 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 osna 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.