Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

To explore the non-inferiority of a cfDNA amplicon-based liquid biopsy technology vs. standard of care tissue biopsy-based NGS in detecting guideline- recommended biomarkers in patients with metastatic non-squamous Non-small Cell Lung Cancer (NSCLC), amongst other endpoints.

To explore the non-inferiority of cfDNA-based LiquidHALLMARK test vs. cfDNA-based liquid biopsy competitor, both qualitatively and quantitatively for actionable mutation (percentage of allele frequency) profile results in a population of subjects who have at least one actionable mutation detected by tissue biopsy.

1. To explore the non-inferiority of a cfDNA amplicon-based liquid biopsy technology vs. standard of care tissue biopsy-based NGS in detecting guideline- recommended biomarkers in patients with metastatic non-squamous Non-small Cell Lung Cancer (NSCLC), amongst other endpoints.
2. To explore the non-inferiority of cfDNA-based LiquidHALLMARK test vs. cfDNA-based liquid biopsy competitor, both qualitatively and quantitatively for actionable mutation (percentage of allele frequency) profile results in a population of subjects who have at least one actionable mutation detected by tissue biopsy.
3. Condition or disease: NSCLC
4. Intervention/treatment: Observational

LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Explore the non-inferiority of cfDNA-based LiquidHALLMARK liquid biopsy assay vs. SOC tissue biopsy based NGS assay for mutation profile results in a population of subjects who have at least one of nine actionable genes (G9) - EGFR, ALK, RET, ROS1, NTRK fusions, MET, BRAF, ERBB2 and KRAS- detected by tissue biopsy.

Lucence Health Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Blood draw

Tissue biopsy of metastatic tissue if undergoing clinical care-directed biopsy

Tissue biopsy

Biomarkers from circulating cell-free tumor DNA in peripheral blood will identify patients with metastatic prostate cancer diagnosed with C11 choline PET/CT who will benefit from metastasis-directed radiation, ablative therapies, and/or surgery. Tissue and blood will be collected before treatment. If patients receive androgen deprivation, then blood will be collected after neoadjuvant androgen deprivation but before radiation, ablative therapies, or surgery. Subsequent samples will be obtained at 3 months and 6 months following treatment, after which no further patient contact will occur.

Genetic Biomarker Discovery for Metastatic Prostate Cancer

ROR1751: Genetic Biomarker Discovery for Metastatic Prostate Cancer

Mayo Clinic

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Estrogens

Progesterone

The Post-hysterectomy tissue biopsy was analyzed immunohistochemically for detection of estrogen and progesterone receptors, P53 and L1CAM

Tissue Biopsy

The incidence of endometrial cancer (EC) is increasing .Different risk classifications are used to direct the primary and adjuvant therapy. The European Society for Medical Oncology - European Society of Gynaecological Oncology -European Society for Radiotherapy \& Oncology (ESMO-ESGO- ESTRO) could guide the need for lymph node surgery pre-operatively, and also post-operatively to determine adjuvant treatment.

Low-risk patients are managed with surgery alone, while higher-risk group patients undergo more aggressive surgical options. So, it is important to identify new prognostic markers for better stratification of patients to avoid under- or over treatment of EC patients.

Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients

Stratification of Endometrial Carcinoma Patients Using Immunohistochemistry for Better Surgical Planning and Prognosis

The Prognostic value of immunohistochemical detection of expression levels of p53/L1CAM/ER/PR in relation to ESMO-ESGO-ESTRO risk groups

Zagazig University

Assistant professor of gynecology

Urinary Bladder Neoplasms

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

During bladder cancer surgery, whole genome gene expression array assays obtained on tumor biopsy specimens. Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC. 3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.

During bladder cancer surgery, tissue specimen taken for molecular profiling.

3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.

Magnetic Resonance Imaging (MRI)

Neema Navai, MD

The goal of this research study is to improve detection of cancer outside of the bladder through genetic testing and improved imaging.

If participant agrees to take part in the study, a piece of the tumor that is removed during the biopsy will be collected for research purposes. The tissue will be sent to the laboratory for genetic testing.

If they have had a computed tomography scan (CT scan) or magnetic resonance imaging scan (MRI) recently, information collected from the scan will be collected. If they have not had one recently, they will have an MRI with contrast as part of this study. They will receive a separate consent form for this MRI scan.

The results of the test will be given to their doctor, but the results will not be used to decide their treatment.

After they have surgery, information will be collected from their medical records, such as their diagnosis.

Length of Study:

* Their participation on this study will be over once their surgery is completed.
* This is an investigational study.

Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.

At the time of biopsy, a portion of the fresh human tumor biopsy samples utilized for DNA and RNA extraction.

Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging

Improved cross sectional imaging with pelvic MRI, and biopsy specimen molecular profiling used to identify muscle invasive bladder cancer (noc-MIBC). Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Neoplastic Cells, Circulating

Breast Diseases

Skin Diseases

Investigators plan to enroll patients who are undergoing biopsy for potential metastatic Breast Cancer any subtype ER/PgR+ and HER2, triple negative or HER2+ at least 6 months before suspected metastases were identified. The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram and MRI

Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy

Blood Draw

Robin Sachdeva, PhD

Lucas Mendez, MD, PhD

Ana Lohmann, MD, PhD

Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. It may also provide information on tumor markers (hormone receptors, HER2) that can guide treatment decisions. The goal of this study is to determine whether blood tests (which require less-invasive procedures) can be used to confirm diagnosis of suspected recurrent breast cancer (as compared to tissue biopsy).

Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood), circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood), as well as other biomarkers. Investigators will conduct this study in 120 participants who present with suspected breast cancer recurrence and symptoms of cancer that has spread to other areas in the body.

Participants will be asked for blood collection within 30 days before tissue biopsy. The tissue will be analysed locally to determine the presence of cancer and the tumor markers listed above. The blood will be processed and stored for analysis of CTCs and ctDNA. If these blood tests show concordance with tissue based tests (presence of cancer cells, hormone receptors \& HER2 status), these tests could be used in future studies to confirm diagnosis using a non-invasive procedure. Also, investigators believe that the results of this study can influence other research of early-stage recurrent breast cancer.

In Canada, it is estimated that more than 26,900 women will be diagnosed with breast cancer (BC), and 5,000 women will die from BC in 2019. Metastatic BC will cause the vast majority of these deaths. Tissue biopsy is recommended to confirm recurrence (presence of cancer cells) in patients with a history of previous BC. Additionally, tissue biopsy provides information on BC subtypes (estrogen receptor (ER), progesterone receptor (PgR), and HER2 status). Technological advances over the last several years have led to more robust methods for the detection, quantification, and characterization of liquid biopsy (including CTCs and ctDNA) in recurrent BC. If these approaches demonstrate sufficiently concordant results to tissue-based testing, blood draws may quickly become a viable alternative to invasive biopsies.

In a cross-sectional study, 120 consecutive individuals from study centers in Ontario, who present with highly suspicious BC distant metastases who undergo biopsy to confirm BC recurrence will be enrolled (enrollment will be continued until 100 subjects with confirmed metastatic breast cancer have been enrolled). Blood samples for the circulating factors will be taken within 30 days prior to the tissue biopsy. Patient and tumor characteristics will be recorded. At the end of study, liquid biopsy (CTCs and ctDNA) analyses will be performed blinded to biopsy results. Investigators will continuously review the number of participants in each BC subtype. Cases with tissue biopsy results not classified as definite or highly suspicious for metastatic breast cancer by the treating physician will be re-assessed after six month of study entry in an attempt to classify them as having metastatic breast cancer or not. This aims to confirm/rule out breast cancer or other diagnosis.

The overall anticipated public and/or scientific benefit of the study is to demonstrate the concordance between liquid (blood) biopsy and tissue based tests in terms of the presence of cancer cells, hormone receptors, HER2 status etc. so these tests could be used in the future to confirm diagnosis using a non-invasive procedure. The results of this study will advance our understanding of liquid biomarkers and ideally improve the care journey for breast cancer patients by not subjecting them to invasive and potentially dangerous biopsy procedures.

Concordance Between Liquid and Tissue Biopsy

Concordance Between Liquid and Tissue Biopsy in Newly Diagnosed Metastatic Breast Cancer

To analyze concordance between liquid biopsy, CTCs (Epic Sciences) and ctDNA (academic assays based on mutations and/or epigenetic changes), with biopsy results (presence or absence of cancer), and with all blood assays being conducted blinded to tissue biopsy results

To conduct secondary analyses of the concordance between hormone receptor and HER2 status identified on tissue specimens with those identified on CTCs (Epic Sciences).

To classify tissue biopsy results according to the interpretation of the local pathologist, the treating physician (primary comparator) and the study investigators (interpretations to include clinical data such as physical exam, radiologic investigations, blood work as available).

To conduct exploratory analyses of the associations between tumor markers and CTCs or ctDNA.

Epic Sciences

University of Western Ontario, Canada

Lunenfeld Tanenbaum Research Institute

MOUNT SINAI HOSPITAL

Toronto Sunnybrook Regional Cancer Centre

University of Toronto

Lawson Health Research Institute

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

-Cabozantinib 60 mg by mouth daily on days 1-21

Cabozantinib should be taken on an empty stomach (at least 1 hour before or 2 hours after eating) at the same time every day.

Cabozantinib

Baseline, cycle 1 day 8, cycle 1 day 15, and day 1 of every cycle thereafter

Blood for plasma biomarkers

Baseline, before start of cycle 2, and time of progression

Nikolaos Trikalinos, M.D.

Benjamin R Tan, M.D.

Esther Lu, M.S., Ph.D.

Rama Suresh, M.D.

Katrina Pedersen, M.D.

Nusayba Bagegni, M.D.

Ryan Fields, M.D.

Olivia Aranha, M.D., Ph.D.

Patrick Grierson, M.D., Ph.D.

Kian-Huat Lim, M.D., Ph.D.

High grade neuroendocrine neoplasm patients are treated with platinum doublets such as carboplatin and etoposide mimicking the current guidelines for small cell lung cancer (SCLC). Unfortunately, recurrences are common and most patients with metastatic disease succumb to it within a year. There is no extensive literature or consensus on second- or third-line options (which include FOLFOX, FOLFIRI, capecitabine and temozolomide, taxanes or immunotherapy) and there is urgent need for better regimens.

Cabozantinib in High Grade Neuroendocrine Neoplasms

* ORR is defined as number of patients with complete response or partial response
* Complete response - Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level.
* Partial response - At least a 30% decrease in the sum of the diameters of the longest diameter of the target lesions taking as reference the baseline sum longest diameter

-OS is defined as days from date of treatment to date of death. Patients alive or lost to follow-up are censored at the follow-up date.

* PFS is defined as the days from the date of treatment and death or progression, which occurs first. Patients alive without progression or lost to follow-up are censored at the last follow-up date.
* Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)	NCT04703153	Non Small Cell ...		21 Years -	Lucence Health Inc.
Genetic Biomarker Discovery for Metastatic Prostate Cancer	NCT03228810	Prostate Cancer	Blood draw Tissue biopsy	18 Years -	Mayo Clinic
Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients	NCT06148129	Endometrial Can...	Tissue Biopsy	36 Years - 72 Years	Zagazig University
Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients	NCT06148129	Endometrial Can...	Tissue Biopsy	36 Years - 72 Years	Zagazig University
Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging	NCT02203136	Bladder Cancer	Tissue Biopsy Magnetic Resona...	-	M.D. Anderson Cancer Center
Concordance Between Liquid and Tissue Biopsy	NCT04241237	Breast Neoplasm...	Blood Draw	18 Years -	Lawson Health Research Institute
Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients	NCT06148129	Endometrial Can...	Tissue Biopsy	36 Years - 72 Years	Zagazig University
Cabozantinib in High Grade Neuroendocrine Neoplasms	NCT04412629	High Grade Neur...	Cabozantinib Blood for plasm... Tissue biopsy	18 Years -	Washington University School of Medicine
Cabozantinib in High Grade Neuroendocrine Neoplasms	NCT04412629	High Grade Neur...	Cabozantinib Blood for plasm... Tissue biopsy	18 Years -	Washington University School of Medicine
Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging	NCT02203136	Bladder Cancer	Tissue Biopsy Magnetic Resona...	-	M.D. Anderson Cancer Center

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