Muscle Invasive Bladder Urothelial CarcinomaNCT06605404
Pan-tumor MRD Study
An observational study of Muscle Invasive Bladder Urothelial Carcinoma and Esophageal Cancer, run by Paradigm Health at 47 sites in United States.
Trial summary
The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer, Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- blood and tissue samples
- How many people
- 1,350 participants
- Where
- 47 sitesUnited States
- Study dates
- 8 Jan 2025to Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors
Eligibility Criteria:
- Age 18 years or older.
- Confirmed histological or cytological diagnosis of a malignant solid tumor that is either specified in one of the pre-defined tumor cohorts or meets the enrollment criteria for the Mix of Solid Tumors (MOST) cohort (Table 1).
- Eligible for curative intent therapy, with surgical resection of cancer planned.
- If surgical resection has occurred, enrollment should occur within 3 months of surgical resection and before initiation of adjuvant therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.
- No systemic therapy for current cancer diagnosis administered before enrollment.
- Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic biopsy or surgical excision.
- Has completed all therapy (including endocrine therapy) 3 or more years ago for any previous invasive solid organ malignancy (with exception of nonmelanoma skin cancers) or hematologic malignancy. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment (no washout period required).
- No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers.
- No prior allogeneic hematopoietic stem cell transplant.
- Able and willing to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information. Cohort Specific Criteria
- Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer:
- Esophageal, Gastric/GEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer.
- Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease.
- MOST cohort: Stage II or operable stage III solid tumor diagnosis that meets eligibility criteria and is not included in the other cohorts.
The following tumor types are excluded:
- Central nervous system (CNS) malignancies
- Colorectal cancer
- Breast cancer
- Squamous cell skin cancer
- Basal cell carcinoma
- Gastrointestinal stromal tumors (GIST)
- Thyroid cancer
- Uveal melanoma
- Low or intermediate grade neuroendocrine tumors ■ Eligible tumor types: High-grade neuroendocrine tumors, including neuroendocrine carcinomas, Merkel cell carcinomas, and small cell lung cancer are permissible
- Hematologic cancers including multiple myeloma or other plasma cell dyscrasias, Hodgkin\'s lymphoma, non-Hodgkin\'s lymphoma, acute or chronic leukemias including chronic lymphocytic leukemia / small lymphocytic leukemia
Trial locations and contacts
47 sites in 1 country. Contact the study team or a site near you to ask about taking part.
47 sites in 1 country
United States47 sites, 47 recruiting
- Recruiting
Piedmont Cancer Institute
Atlanta, Georgia, 30318
Katie Adams, 678-298-3238, kadams@piedmontcancerinstitute.com
Vasileios Assikis
- Recruiting
Guthrie Lourdes Memorial Hospital (GLMH)
Binghamton, New York, 13905
Colleen English, (607)798-5734, colleenh.english@guthrie.org
Beka Aroshidze
- Recruiting
Alabama Oncology
Birmingham, Alabama, 35205
Kailee Hawkins, 919-368-3285, kailee.hawkins@alabamaoncology.com
Carter Capra
- Recruiting
Mohtaseb Cancer Center and Blood Disorders
Bullhead City, Arizona, 86442
Stephanye Vargas, 928-219-4560, stephanye@azcancerandblood.com
Hamdy Mohtaseb
- Recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
Carrie Smith, 330-417-8231, csmith@gabrailcancercenter.com
Nashat Gabrail
- Recruiting
Cancer & Blood Specialists of Arizona
Casa Grande, Arizona, 85122
Robin Wilson, 520-836-9800, robin.wilson@aoncology.com
Carlos Arce-Lara
- Recruiting
Carolina Oncology Specialists
Charlotte, North Carolina, 28207
Tine Ekhaiyeme, 704-342-1900 Ext 1126, aekhaiyeme@carolinaonco.com
Justin Favaro
- Recruiting
Oncology & Hematology Associates of West Broward
Coral Springs, Florida, 33065
Margie Murillo, 954 726 0035 x1230, margie.murillo@ohawb.com
Sumit Sawhney
- Recruiting
Baptist Health Corbin
Corbin, Kentucky, 40701
Janie Platt, 859.260.6406, Janie.platt@bhsi.com
Abigail Byrnes
- Recruiting
Pontchartrain Cancer Center
Covington, Louisiana, 70433
Ella Hunter, 985-419 0025, ella@pcclouisiana.com
David Oubre
- Recruiting
Baptist Health Hardin
Elizabethtown, Kentucky, 42701
Kristen Lerch, 270-979-2686, Kristen.Lerch@bhsi.com
Christopher Burkeen
- Recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
Sydney Harris, 720-316-8091 extn 101, sydney.harris@theskincancerinstitute.com
Ryan Weight
- Recruiting
San Juan Oncology Associates
Farmington, New Mexico, 87401
Jessica Barnes, (505)564-6850 ext 875, jessica@sjonc.com
Sardar Imam
- Recruiting
Los Angeles Cancer Network (LACN)
Glendale, California, 91204
Robert Milford, (323) 794-1132 Ext: 3734, robert.milford@lahomg.com
Peyman Salimi-Tari
- Recruiting
Southeastern Medical Oncology Center (SMOC)
Goldsboro, North Carolina, 27534
Mackenzie Lupton, 919-429-4318, mlupton@cancersmoc.com
Samer Kasbari
- Recruiting
The Cancer & Hematology Centers (CHC)
Grand Rapids, Michigan, 49546
Maci Deboer, (616) 954-5550 Ext. 1925, mdeboer@hcwm.com
Joy Bartholomew
- Recruiting
Onocology Consultants P.A. (Oncology Consultants [OC Houston])
Houston, Texas, 77030
Marisol Dominguez, (832) 333-1480, marisol.dominguez@aoncology.com
Julio Peguero
- Recruiting
Community Clinical Trials
Kingwood, Texas, 77339
Kemi Stewart, 325-298-7478, kemi@communityclinicaltrials.com
Saleha Sajid
- Recruiting
Lancaster General Hospital (UPenn)
Lancaster, Pennsylvania, 17601
Susan Tollett, 717-544-0511, susan.tollett@pennmedicine.upenn.edu
Efrat Dotan
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
Tory Tincher, 859.260.6464, Tory.Tincher@bhsi.com
Arvinda Padmanabhan
- Recruiting
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516
Candice Toombs, 402-327-7363, candicet@cancerpartners.com
Stacey Knox
- Recruiting
CARTI
Little Rock, Arkansas, 72205
Carla Randall, 501-906-3012, Crandall@carti.com
Andrew Briggler
- Recruiting
Baptist Health Louisville
Louisville, Kentucky, 40207
Kelly Strange, 502.928.6103, Kelly.Strange@bhsi.com
Wangjian Zhong
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43437
Jennifer Martinez, 419-479-5605 ext. ext 4134, jmartinez@toledoclinic.com
- Recruiting
Cancer Care Specialists of Illinois (CCSI)
O'Fallon, Illinois, 62269
Kaitlynn Zeisset, 618-589-9721, kzeisset@ccsci.net
James Wade
- Recruiting
Mid Florida Cancer Centers
Orange City, Florida, 32763
Kiran Penta, 386-538-3169, Kiran@aocorp.com
Santosh Nair
- Recruiting
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030
Cheryl Senour, 805-485-8709 x 121, csenour@venturaoncology.com
Lynn Kong
- Recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97201
Francis DeAsis, (503) 418-8155, deasis@ohsu.edu
Nima Nabavizadeh
- Recruiting
Virginia Cancer Institute
Richmond, Virginia, 23229
Christine Mathews, 1-804-287-3000 ext 1260, cmathews@vacancer.com
Susan Moore
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Lauren Helgeson, 507-266-3718, helgeson.lauren@mayo.edu
Lisa Boardman
- Recruiting
Medical Oncology Associates of San Diego (MOASD)
San Diego, California, 92123
Amanda Somo, (858) 637-7888 ext 224, asomo@oncologysandiego.com
James Coggan
- Recruiting
Medical Oncology Associates of San Diego
San Diego, California, 92123
Alexis Bustamante, abustamante@oncologysandiego.com
- Recruiting
Guthrie Foundation
Sayre, Pennsylvania, 18840
Jackie Cole, (570)887-6071, jacqueline.cole@guthrie.org
Rebekah Macfie
- Recruiting
New York Cancer & Blood Specialists
Shirley, New York, 11967
Stella Smaragdas, 631-675-5075, ssmaragdas@nycancer.com
Richard Zuniga
- Recruiting
Christus Health Highlands
Shreveport, Louisiana, 71105
Nancy Hassan, 318.681.4763, nancy.senniah@christushealth.org
Neelima Chintapalli
- Recruiting
Highlands Oncology Group (HOG)
Springdale, Arkansas, 72762
Tina Patrick, 479-872-8130, tpatrick@hogonc.com
Joseph Beck
- Recruiting
Cox Health
Springfield, Missouri, 65807
Tala Abu Zahra, 417-269-7114, Tala.AbuZahra@coxhealth.com
Rajesh Banderudrappagari
- Recruiting
Comprehensive Hematology Oncology (CHO)
St. Petersburg, Florida, 33709
Raj Shah, 727-344-6569 Ext 1036, rshah@comphemonc.com
Neeharika Makani
- Recruiting
Stockton Hematology Oncology Med Group
Stockton, California, 95204
Lenzi Cook, 209-938-3106, lcook@shomg.net
Sunny Phillip
- Recruiting
Northwest Medical Specialties (NWMS)
Tacoma, Washington, 98405
Erma Sanders, 253-428-8700, esanders@nwmsonline.com
Manas Agastya
- Recruiting
Christus St. Michael's
Texarkana, Texas, 75503
Kimberly Everett, 903-614-6885, kimberly.everett@christushealth.org
Sunil Patel
- Recruiting
Cotton O'Neil Cancer Center [Stormont Vail]
Topeka, Kansas, 66606
Scott Harrison, 785-270-4962, saharris@stormontvail.org
Mehmmod Hashmi
- Recruiting
Oklahoma Cancer Specialists and Research Institute (OCSRI)
Tulsa, Oklahoma, 74129
Stephanie Sandoval, 918-568-6759, stephanie.sandoval@ocsri.org
Scott Cole
- Recruiting
Carle Health
Urbana, Illinois, 61801
Christine Canfield, (217) 326-0095, christine.canfield@carle.com
Christine Canfield
- Recruiting
Cancer Center of Kansas
Wichita, Kansas, 67214
Kristen Mazowiecki, (316) 613-4326, kristen.mazowiecki@cancercenterofkansas.com
Shaker Dakhil
- Recruiting
Regional Medical Oncology Center
Wilson, North Carolina, 27893
Meredith Best, (252) 991-5261, meredith.best@regionaloncology.com
Keith Lerro
- Recruiting
Cancer Care Associates of York (CCAY)
York, Pennsylvania, 17403
Clarissa Vega, 717-741-9229 EXT: 147, cvega@cancercareyork.com
Chanh Huynh
About this study
Official title: Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers
The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back.
Participants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer, Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Melanoma (Skin Cancer), NSCLC (Non-small Cell Lung Cancer), Pancreatic (Exocrine Only)
- Being tested
- blood and tissue samples
- Keywords
- observational, biospecimen, routine care
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma, Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and tissue samplesDiagnostic test
routine standard of care
blood and tissue samplesOther
Routine standard of care
| Study group | Role | What they receive |
|---|---|---|
| Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC) | Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC) Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples | |
| Esophageal | Esophageal cancer Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples | |
| Gastric and Gastroesophageal Junction (GEJ) | Gastric and Gastroesophageal Junction (GEJ) Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples | |
| Melanoma | Melanoma Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples | |
| Non-small cell lung (NSCLC) | Non-small cell lung (NSCLC) Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples | |
| Pancreatic (exocrine only) | Pancreatic (exocrine only) Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples | |
| Mix of Solid Tumors (MOST) | Mix of Solid Tumors (MOST) Receives: Diagnostic Test: blood and tissue samples; Other: blood and tissue samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood and tissue biospecimen registry
To establish a blood and tissue biospecimen resource in participants with operable solid tumors, with clinical, lab, radiographic, and pathology annotation for the discovery, development, and validation of MRD assays.
Measured: Observation from enrollment to 5.5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start8 Jan 2025
- Primary completionDec 2031 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paradigm Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605404
- Sponsor's protocol ID
- PHPE-07-002
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers
- ClinicalTrials.gov ID
- NCT06605404
- Acronym / sponsor ID
- PHPE-07-002
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer, Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Melanoma (Skin Cancer), NSCLC (Non-small Cell Lung Cancer), Pancreatic (Exocrine Only)
- Keywords
- observational, biospecimen, routine care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Paradigm HealthIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back.
Participants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC) | – | Diagnostic Test: blood and tissue samples, Other: blood and tissue samplesMuscle Invasive Urothelial Carcinoma of the Bladder (MIBC) |
| Esophageal | – | Diagnostic Test: blood and tissue samples, Other: blood and tissue samplesEsophageal cancer |
| Gastric and Gastroesophageal Junction (GEJ) | – | Diagnostic Test: blood and tissue samples, Other: blood and tissue samplesGastric and Gastroesophageal Junction (GEJ) |
| Melanoma | – | Diagnostic Test: blood and tissue samples, Other: blood and tissue samplesMelanoma |
| Non-small cell lung (NSCLC) | – | Diagnostic Test: blood and tissue samples, Other: blood and tissue samplesNon-small cell lung (NSCLC) |
| Pancreatic (exocrine only) | – | Diagnostic Test: blood and tissue samples, Other: blood and tissue samplesPancreatic (exocrine only) |
| Mix of Solid Tumors (MOST) | – | Diagnostic Test: blood and tissue samples, Other: blood and tissue samplesMix of Solid Tumors (MOST) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and tissue samplesroutine standard of care | Diagnostic test | Esophageal, Gastric and Gastroesophageal Junction (GEJ), Melanoma, Mix of Solid Tumors (MOST), Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC), Non-small cell lung (NSCLC), Pancreatic (exocrine only) |
| blood and tissue samplesRoutine standard of care | Other | Esophageal, Gastric and Gastroesophageal Junction (GEJ), Melanoma, Mix of Solid Tumors (MOST), Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC), Non-small cell lung (NSCLC), Pancreatic (exocrine only) |
Primary outcome
Blood and tissue biospecimen registry
Time frame: Observation from enrollment to 5.5 years after enrollment
To establish a blood and tissue biospecimen resource in participants with operable solid tumors, with clinical, lab, radiographic, and pathology annotation for the discovery, development, and validation of MRD assays.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Invasive Bladder Urothelial Carcinoma and Esophageal Cancer, run by Paradigm Health at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anosheh Afghahi, MD (888-662-6367, anosheh.afghahi@paradigmhealth.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood and tissue biospecimen registry (time frame: Observation from enrollment to 5.5 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.