Neoplasms

All Conditions

Digestive System Diseases

Adenocarcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Leftover sample of tumor tissue from a previous procedure used for biomarker testing. Blood drawn for biomarker testing, to check for levels of cytokines, and to check the circulating tumor cells (CTCs). Cancer Symptom Questionnaire completion about cancer symptoms.

5 minute questionnaire(s) completed at each study visit.

Cancer Symptom Questionnaire

Blood draw at each study visit for biomarker and cytokine testing.

Biomarker Testing

Scott Kopetz, MD

The goal of this clinical research study is to test for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical "markers" in the tumor tissue and/or blood that may be related to your reaction to cancer drugs.

This is an investigational study. This study's biomarker testing is for research purposes only.

Up to 1280 patients will be enrolled in this study. All will be enrolled at MD Anderson.

The effectiveness of drugs used to treat colorectal cancer may be different from person to person. Researchers want to learn if certain biomarkers can be used to help predict which cancer drugs may work better than other drugs in different people with colorectal cancer.

Study Participation:

If you agree to take part in this study, the following tests and procedures will be performed:

* A leftover sample of tumor tissue from a previous procedure, if available, will be used for biomarker testing.
* Blood (about 3 tablespoons) will be drawn for biomarker testing, to check for levels of cytokines (proteins that may affect the immune system), and to check the circulating tumor cells (CTCs) in your blood.
* You will be asked how well you are able to perform the normal activities of daily living (performance status).

You will also fill out a questionnaire about the cancer symptoms. This should take about 5 minutes.

Biomarker Test Results:

The study doctor and staff will review the biomarker test results with you.

If the results seem to show that a certain investigational drug may help to control the cancer, and the drug is available through a separate MD Anderson clinical research study called a "companion" drug study, your doctor may recommend that you have additional tests and procedures performed. The tests and procedures will be performed as part of the companion drug study to see if you are eligible to receive that drug. You will be asked to sign a separate consent form for the companion drug study.

It is possible that the biomarker test results may seem to show that more than one drug may help to control the cancer. If so, it may be possible that you could receive the other drug(s) under other companion studies in the future. The study tests described below would be repeated during those other studies as well.

Even if the biomarker testing shows that a certain drug may be helpful, it is possible that you may not be eligible to take part in the separate companion drug study, the study drug may not be available, or there may be other reasons you cannot take part in the drug study. You may also decide that you do not want to take part in the companion drug study. Your doctor will discuss other available treatment options with you.

Study Visits:

At study visits for this biomarker research study, the following tests and procedures will be performed:

* You will fill out the cancer symptom questionnaire.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for biomarker, cytokine, and CTC testing.

Your schedule of study visits will depend on whether or not you take part in a companion study. There is a different schedule of visits for participants who do not take part in a companion study but instead either take part in a clinical research study that is not a companion study or they receive standard cancer drug(s).

If you take part in 1 or more companion studies, you will have study visits for this biomarker research study on the following schedule:

* before you start taking the drug(s) if you join a companion drug study and it has been 2 or more weeks since you had these tests done (note: the amount of blood drawn will be about 2 tablespoons at this visit)
* each time you return for imaging scans during the time that you take part in 1 or more companion drug studies
* after you stop taking part in a companion drug study

If your first treatment after consenting to this biomarker research study is part of a clinical research study that is not a companion study or if you receive standard cancer drug(s), you will have study visits for this biomarker research study on the following schedule:

* before you start taking the drug(s) during your first treatment period at MD Anderson and it has been 2 or more weeks since you had these tests done (note: the amount of blood drawn will be about 2 tablespoons at this visit)
* each time you return for imaging scans during your first treatment period at MD Anderson
* after you first stop taking part in a clinical research study that is not a companion drug study, or until you first stop taking standard cancer drug(s).

Length of Treatment:

The study testing will continue:

* for as long as you are taking part in a companion drug study, or
* until you first stop taking part in a clinical research study that is not a companion drug study, or until you first stop taking standard cancer drug(s), if you do not take part in a companion drug study.

Follow-Up Visit:

If you stop taking part in this study:

* You will fill out the cancer symptom questionnaire.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for biomarker, cytokine, and CTC testing.

Long-Term Follow-Up:

After your follow-up visit, from then on, the research staff will collect information on your health status, the drug(s) you receive, and the status of the disease. This information may be collected at the time of standard clinic visits, by reviewing your medical record and imaging scans, and/or by contacting you by phone, mail, and/or email. If you are called, the call will last about 10 minutes or less.

Blood (16 mL) collected and archived tumor samples (primary tumor or metastatic site) from prior surgeries or biopsies.

Colorectal Cancer Umbrella Protocol - Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC Program) Screening Protocol

Assessment of Targeted Therapy Against Colorectal Cancer (ATTACC) Screening Protocol

Descriptive analysis performed to report the frequency of informative biomarkers for each of the companion allocation biomarkers as a proportion of patients enrolled onto the study. The primary analysis will be number of patients where informative biomarker results were determined for all tested biomarkers divided by the total number of patients enrolled on the study. Results reported separately for each of the individual biomarkers. Reasons for non-informative results reported descriptively.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Rare Diseases

Cholangiocarcinoma

Neoplasms, Unknown Primary

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasm Metastasis

Neoplastic Processes

Bile Duct Cancer

Eligible patients that present with Cholangiocarcinoma.

Eligible patients with cancer of unknown primary site (CUP).

Eligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States).

Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.

FoundationOne CDx and FoundationOne Liquid CDx

Mary Oster

Shumei Kato, M.D

Razelle Kurzrock, M.D.

Vivek Subbiah, M.D.

Shumei Kato, M.D.

This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results.

This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results. The study leverages a remote consent and participation approach to open enrollment to all patients with rare tumors within the United States. Traditional, site-based patient consenting and participation is also available for enrollment to the study.

Each participant will undergo comprehensive genomic profiling (CGP) by Foundation Medicine Inc. (FMI) of their tumor as well as plasma circulating cell-free DNA. Plasma circulating cell-free DNA may be additionally collected for repeat CGP at various timepoints during the study.

The CGP findings will be provided by FMI directly to the treating physician and study sponsor TargetCancer Foundation (TCF), with TCF presenting cases with genomic findings to the Virtual Molecular Tumor Board (VMTB). The VMTB will analyze the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions. The resultant treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

The primary feasibility endpoint is the percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. Point estimates and confidence interval estimations will be calculated for percent of participants on matched treatments.

The primary efficacy endpoint is the progression-free survival (PFS) among participants who received the molecularly targeted matched treatment. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including progression-free survival (PFS). Cox regression analysis will be applied to model PFS by putative covariates such as performance status, type of tumor, prior lines of treatment, and whether matched treatments are received.

Tumor molecular profiles will be correlated to treatment outcome, assessed by measures including the response rate, the rate of stable disease (SD)\>6 months/partial response (PR)/complete response (CR), progression-free survival (PFS), PFS ratio (comparison of the PFS used after molecular profiling to PFS on prior treatment), time to treatment failure, and overall survival. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including overall survival (OS).

Foundation Medicine

TargetCancer Foundation

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Makenzi Evangelist, MD

This pragmatic study looks to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a large, community-based, and largely unselected patient population with early stage and advanced stage, treatment-naive non-small cell lung cancer, whether squamous or non-squamous.

Lung cancer remains the most lethal malignancy in men and women in the U.S. Providing high quality management of these patients in the community setting as compared to hospital or academic centers offers the opportunity to reduce cost without sacrificing clinical outcome and simultaneously improving patient convenience and value. Many patients diagnosed with late-stage cancers can benefit from advanced biomarker testing, yet not all eligible patients receive this type of diagnostic testing today.

Within advanced non-small-cell lung cancer (aNSCLC), there are many specific somatic mutations observed in select patient populations that have targeted highly effective and less toxic therapies. National guidelines have advocated for broad tumor molecular profiling as a part of the standard diagnostic evaluation for aNSCLC, with the goal of identifying driver mutations for which effective therapies or clinical trials are available.

Furthermore, there is emerging evidence that molecular testing can impact treatment choices in earlier stages of lung cancer. However, adherence to genomic testing guidelines presents unique challenges to community oncologists. While most oncology clinical research has been conducted at well-established academic medical centers, over 85% of cancer patients are diagnosed and treated at local, community-based clinical practices. Barriers exist in the ability to order these tests efficiently, in a timely manner, and reimbursed accordingly. Furthermore, patient care can vary drastically based on community-associated disparities.

This pragmatic clinical trial will generate Real World Evidence (RWE) to validate efficacy of first treatment regimen in newly diagnosed patients with non-small cell lung cancer. The MYLUNG Program integrates three separate protocols: Protocol #1 will interrogate historical data from a large number of practices seeing lung cancer patients to evaluate biomarker testing, decision making patterns, the patient journey, and the tissue journey; Protocol #2 (current trial) will prospectively evaluate the patient journey in a limited number of index practices focused on testing; integration of testing results; and treatments. Interventional strategies to optimize these objectives will be developed and integrated into Protocol #3, which will evaluate the impact of these strategies on the patient journey as it relates to shared decision making.

MYLUNG Consortium Study Protocol 2

Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Prospective RWE Study (MYLUNG Consortium: Part 2)

i. Comprehensive testing is defined as both PD-L1 testing to guide use of immunotherapies \& testing for all genomic alterations for which we have FDA-approved therapies incl EGFR, ALK, ROS1, BRAF, NTRK, RET, KRAS \& MET ii. Document whether patient receives single gene testing for actionable mutations compared to those who receive comprehensive testing. For patients who start systemic therapy prior to or without biomarker results, we will catalog reasons for not conducting testing incl:

1. Clinical deterioration, clinical crisis
2. Insufficient tissue
3. Barriers to test ordering

   1. Tissue: obtaining sample, tissue retrieval
   2. Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), QA fail, test failure
   3. Patient/provider attitudes \& perceptions
   4. Provider knowledge about testing options
   5. Patient knowledge about biomarker testing
   6. Payor Coverage: prior authorization denial, payor refusal
   7. Financial barriers: uncovered costs, reimbursement

To determine the proportion of patients placed on biomarker-directed first treatment regimen. For patients who have received biomarker test results with at least one actionable mutation, catalog the reason for not prescribing biomarker-targeted therapy.

i. Lack of availability or delays in obtaining targeted therapy ii. Misinterpretation of test results iii. Clinical contraindications (allergies, end organ dysfunction, active autoimmune disease, etc.) iv. Patient/provider attitudes and perceptions v. Financial barriers / Uncovered costs vi. Patient performance status

Characteristics of the cancer care practices include, but not limited to, number of geographic clinic locations, clinical settings (rural or urban), staffing and responsibilities, patient volumes, and Oncology Care Model (OCM) status.

US Oncology Research

Andrea Glidden, BSN, OCN

Taqi Mohammad

Karla Childers

Michael Meshad, MD

Erika Arguello Vargas

Allan V. Espinosa Morazan, MD

Venkat Pavan R. Kancharla, MD

Angela Malone

Rami Y. Haddad, MD

Ambri Cicchinelli

Sara Gonce

Patrick J. Ward, MD

Jeanne Schaffer

James E. Butrynski, MD

Natasha R. Holt

Jerome H. Goldschmidt, Jr., MD

Ebony Villarson

John C. Paschold, MD

Julian Kern

Anthony Van Ho, MD

Makenzi C. Evangelist, MD

This longitudinal study looks to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a large, community-based, and largely unselected patient population with early stage and advanced stage, treatment-naive non-small cell lung cancer, whether squamous or non-squamous.

Lung cancer remains the most lethal malignancy in men and women in the U.S. Providing high quality management of these patients in the community setting as compared to hospital or academic centers offers the opportunity to reduce cost without sacrificing clinical outcome and simultaneously improving patient convenience and value. Many patients diagnosed with late-stage cancers can benefit from advanced biomarker testing, yet not all eligible patients receive this type of diagnostic testing today.

Within advanced non-small-cell lung cancer (aNSCLC), there are many specific somatic mutations observed in select patient populations that have targeted highly effective and less toxic therapies. National guidelines have advocated for broad tumor molecular profiling as a part of the standard diagnostic evaluation for aNSCLC, with the goal of identifying driver mutations for which effective therapies or clinical trials are available.

Furthermore, there is emerging evidence that molecular testing can impact treatment choices in earlier stages of lung cancer. However, adherence to genomic testing guidelines presents unique challenges to community oncologists. While most oncology clinical research has been conducted at well-established academic medical centers, over 85% of cancer patients are diagnosed and treated at local, community-based clinical practices. Barriers exist in the ability to order these tests efficiently, in a timely manner, and reimbursed accordingly. Furthermore, patient care can vary drastically based on community-associated disparities.

This longitudinal clinical trial will generate Real World Evidence (RWE) to validate efficacy of first treatment regimen in newly diagnosed patients with non-small cell lung cancer. The MYLUNG Program integrates three separate protocols: Protocol #1 interrogated historical data from a large number of practices seeing lung cancer patients to evaluate biomarker testing, decision making patterns, the patient journey, and the tissue journey; Protocol #2 prospectively evaluated the patient journey in a limited number of index practices focused on testing; integration of testing results; and treatments. Interventional strategies to optimize these objectives will be developed and integrated into various interventions all aimed at improving biomarker testing rates. Protocol #3 (22285) will serve as a resource to monitor the impact of these strategies on the patient journey as it relates to shared decision making, and will continue to prospectively evaluate the patient journey in a limited number of index practices focused on testing, integration of testing results and treatments.

MYLUNG Consortium Part 3: Observational Study

Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Longitudinal Prospective RWE Study (MYLUNG Consortium Part 3: Observational Study)

Comprehensive biomarker testing is defined as both PD-L1 testing to guide the use of immunotherapies and testing for all genomic alterations for which there are FDA-approved therapies including (but not limited to) EGFR, ALK, ROS1, BRAF, NTRK, RET, KRAS and MET.

1. Clinical deterioration, clinical crisis
2. Tissue: obtaining sample, tissue retrieval
3. Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), Quality Assurance (QA) fail, test failure
4. Patient/provider attitudes \& perceptions
5. Provider knowledge about testing options
6. Patient knowledge about biomarker testing
7. Payor Coverage: prior authorization denial, payor refusal
8. Financial barriers: uncovered costs, reimbursement

For patients who have received biomarker test results with at least one actionable mutation, catalog the reason for not prescribing biomarker-targeted therapy.

1. Lack of availability or delays in obtaining targeted therapy
2. Misinterpretation of test results
3. Clinical contraindications (allergies, end organ dysfunction, active autoimmune disease, etc.)
4. Patient/provider attitudes and perceptions
5. Financial barriers / Uncovered costs
6. Patient performance status

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colorectal Cancer Umbrella Protocol - Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC Program) Screening Protocol	NCT01196130	Colorectal Canc...	Cancer Symptom ... Biomarker Testi...	18 Years -	M.D. Anderson Cancer Center
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
MYLUNG Consortium Study Protocol 2	NCT05644808	Carcinoma, Non-...		18 Years -	US Oncology Research
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
MYLUNG Consortium Part 3: Observational Study	NCT05885698	Carcinoma, Non-...		18 Years -	US Oncology Research

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