NCT05179824

Brief Summary

Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with the goal of conducting research to advance cancer care and create a dataset that furthers cancer research.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Oct 2020Oct 2030

Study Start

First participant enrolled

October 19, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2030

Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

6 years

First QC Date

December 16, 2021

Last Update Submit

May 5, 2025

Conditions

Breast CancerProstate CancerBladder CancerLung CancerBrain CancerPancreatic CancerOvarian CancerFallopian Tube CancerPeritoneal CancerCancer of LiverCancer of ColonCancer of Head and NeckCancer of StomachCancer of Gastrointestinal TractCancer of RectumCancer of EsophagusCancer of SkinCancer of CervixCancer of KidneyCancer of LarynxCancer of EndometriumCancer of the Bile DuctCancer of VulvaCancer of Bone and Connective TissueLeukemiaLymphomaSpinal Cord Cancer

Keywords

CancerOncologyObservationalGenomic ProfilingPrecision Medicine

Outcome Measures

Primary Outcomes (1)

  • Create robust data set of health information

    To create a robust data set of health information about cancer patients who receive comprehensive genomic profiling in order to facilitate future novel precision medicine research

    Up to 10 years

Secondary Outcomes (2)

  • Document clinical events for patients who have had comprehensive genomic profiling

    Up to 10 years

  • Evaluate longitudinal paired tissue and cell free molecular testing

    Up to 10 years

Other Outcomes (3)

  • Support prospective and retrospective research studies

    Up to 10 years

  • Describe real world treatment outcomes

    Up to 10 years

  • Review medical information for standard of care decisions and health outcomes

    Up to 10 years

Study Arms (1)

Group 1: Standard of Care (SOC) CGP

This group will facilitate collection of paired clinical and molecular data done as part of the standard of care or routine clinical care across a variety of institutions. The goal of Group 1 is to capture a broad range of participants to better understand longitudinal outcomes across institutions and standards of care.

Other: Observation

Interventions

ObservationOTHER

No Intervention

Group 1: Standard of Care (SOC) CGP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This protocol targets a broad spectrum of cancer patients with comprehensive genomic profiling.

You may qualify if:

  • Solid or hematologic malignancy.
  • Willing and able to provide informed consent where required.
  • Has received or will receive genomic profiling.

You may not qualify if:

  • Individuals without the capacity to consent.
  • Prisoners at the time of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UT Southwestern

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Zehir A, Benayed R, Shah RH, Syed A, Middha S, Kim HR, Srinivasan P, Gao J, Chakravarty D, Devlin SM, Hellmann MD, Barron DA, Schram AM, Hameed M, Dogan S, Ross DS, Hechtman JF, DeLair DF, Yao J, Mandelker DL, Cheng DT, Chandramohan R, Mohanty AS, Ptashkin RN, Jayakumaran G, Prasad M, Syed MH, Rema AB, Liu ZY, Nafa K, Borsu L, Sadowska J, Casanova J, Bacares R, Kiecka IJ, Razumova A, Son JB, Stewart L, Baldi T, Mullaney KA, Al-Ahmadie H, Vakiani E, Abeshouse AA, Penson AV, Jonsson P, Camacho N, Chang MT, Won HH, Gross BE, Kundra R, Heins ZJ, Chen HW, Phillips S, Zhang H, Wang J, Ochoa A, Wills J, Eubank M, Thomas SB, Gardos SM, Reales DN, Galle J, Durany R, Cambria R, Abida W, Cercek A, Feldman DR, Gounder MM, Hakimi AA, Harding JJ, Iyer G, Janjigian YY, Jordan EJ, Kelly CM, Lowery MA, Morris LGT, Omuro AM, Raj N, Razavi P, Shoushtari AN, Shukla N, Soumerai TE, Varghese AM, Yaeger R, Coleman J, Bochner B, Riely GJ, Saltz LB, Scher HI, Sabbatini PJ, Robson ME, Klimstra DS, Taylor BS, Baselga J, Schultz N, Hyman DM, Arcila ME, Solit DB, Ladanyi M, Berger MF. Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients. Nat Med. 2017 Jun;23(6):703-713. doi: 10.1038/nm.4333. Epub 2017 May 8.

    PMID: 28481359BACKGROUND

  • Daoud A, Chu QS. Targeting Novel but Less Common Driver Mutations and Chromosomal Translocations in Advanced Non-Small Cell Lung Cancer. Front Oncol. 2017 Sep 29;7:222. doi: 10.3389/fonc.2017.00222. eCollection 2017.

    PMID: 29034207BACKGROUND

  • Ersek JL, Black LJ, Thompson MA, Kim ES. Implementing Precision Medicine Programs and Clinical Trials in the Community-Based Oncology Practice: Barriers and Best Practices. Am Soc Clin Oncol Educ Book. 2018 May 23;38:188-196. doi: 10.1200/EDBK_200633.

    PMID: 30231363BACKGROUND

  • Griffith SD, Tucker M, Bowser B, Calkins G, Chang CJ, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA. Generating Real-World Tumor Burden Endpoints from Electronic Health Record Data: Comparison of RECIST, Radiology-Anchored, and Clinician-Anchored Approaches for Abstracting Real-World Progression in Non-Small Cell Lung Cancer. Adv Ther. 2019 Aug;36(8):2122-2136. doi: 10.1007/s12325-019-00970-1. Epub 2019 May 28.

    PMID: 31140124BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Archival tissue will be collected.

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsUrinary Bladder NeoplasmsLung NeoplasmsBrain NeoplasmsPancreatic NeoplasmsOvarian NeoplasmsFallopian Tube NeoplasmsLiver NeoplasmsColonic NeoplasmsHead and Neck NeoplasmsStomach NeoplasmsGastrointestinal NeoplasmsRectal NeoplasmsEsophageal NeoplasmsSkin NeoplasmsUterine Cervical NeoplasmsKidney NeoplasmsLaryngeal NeoplasmsEndometrial NeoplasmsBile Duct NeoplasmsVulvar NeoplasmsBone NeoplasmsLeukemiaLymphomaNeoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder DiseasesUrologic DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersFallopian Tube DiseasesLiver DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesStomach DiseasesRectal DiseasesEsophageal DiseasesUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesKidney DiseasesOtorhinolaryngologic NeoplasmsLaryngeal DiseasesOtorhinolaryngologic DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesVulvar DiseasesBone DiseasesMusculoskeletal DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Kristiyana Kaneva, MD, MS, MBA

    Tempus AI, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 5, 2022

Study Start

October 19, 2020

Primary Completion (Estimated)

October 19, 2026

Study Completion (Estimated)

October 19, 2030

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)