Malignant NeoplasmNCT04185935
Molecular Genetics Studies of Cancer Patients and Their Relatives
An observational study of Malignant Neoplasm, run by City of Hope Medical Center at 42 sites in 5 countries.
Trial summary
This trial studies the genetic and behavioral factors that may contribute to the development of specific cancers and how these factors may affect the outcome of the disease in patients with a history of cancer and their relatives. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Biospecimen Collection and Questionnaire Administration
- How many people
- 999,999 participants
- Where
- 42 sitesin 5 countries
- Study dates
- 18 Apr 1997to 18 Aug 2033
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with a family history of cancer
Who may be able to join
- Individuals must have a personal history of cancer and/or a family history of cancer suggestive of the presence of an inherited predisposition. This inherited predisposition might manifest as:
- Young age cancer diagnosis
- Multiple primary neoplasms in affected member
- The presence of rare tumor types in the family
- Congenital malformations
- Any other family clustering of cancer
Show all 12Show fewer
- Any other cancer-predisposing genetic diseases/conditions
- Individuals may also be eligible by participation in the City of Hope Cancer Screening \& Prevention Program Network (CSPPN) clinical service or on the basis of membership in a group known or suspected to have an increased risk of carrying a genetic alteration or of sustaining a particular exposure that would place that at increased risk of cancer. (Examples would include members of occupational cohorts like asbestos workers, individuals with multiple dysplastic nevi in the absence of a family history of cancer, and individuals descended from a particular tribe in the American Southwest who have an increased incidence of a rare genetic alteration associated with an increased risk of a specific cancer.)
- Individuals and families may be referred to us in a number of different ways. After initial contact is made with a individual or family by family studies personnel; an individual within the bloodline will be identified as the historian. There may be more than one historian within a family
- At least one historian must be wiling to provide information or access as needed to contact appropriate family members for documentation of cancer and for consent. An individual is considered to be eligible to participate if they criteria; contact with relatives is not always indicated
- Individuals who are under 18 are eligible for study if they meet the criteria. Consent for participation must be given by a legal guardian or parent
- Deceased patients may be included in the study. Public records, such as death certificates, can be used to confirm information from individuals or family members. If medical records are needed, consent for these records will be obtained from the deceased's next of kin. Next of kin refers to the following hierarchy of relatives; spouse, offspring, parents, and siblings. (Any further use of next of kin in this protocol should relate back to this hierarchy.) Archived tissue samples, such as pathology blocks or snap frozen tumor from a pathology department tumor bank (discard specimens) may be used for genetic research
Who cannot join
- A family may be ineligible for study if the historian will not allow access to anyone within the family and thus, the accuracy of the family history cannot be established
Trial locations and contacts
42 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Stephen Gruber contact
42 sites in 5 countries
United States35 sites, 35 recruiting
- Recruiting
Lovelace Medical Center-Downtown
Albuquerque, New Mexico, 87102
Malcolm H. Purdy, 505-727-3040, malcolm.purdy@ardenthealth.com
Malcolm H. Purdy
- Recruiting
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
Annette C. Fontaine, 505-480-1462, afontaine@nmohc.com
Annette C. Fontaine
- Recruiting
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Kenneth J. Smith, 505-559-6143
Kenneth J. Smith
- Recruiting
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
Anita Ravipati, aravipati@harringtoncc.org
Anita Ravipati
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Coralia B. Calomeni, 541-706-5800, cbcalomeni@stcharleshealthcare.org
Coralia B. Calomeni
- Recruiting
Suburban Hospital
Bethesda, Maryland, 20814
Carolyn B. Hendricks, 301-897-1503, carolyn.hendricks53@verizon.net
Carolyn B. Hendricks
- Recruiting
Lynn Regional Cancer Center - West
Boca Raton, Florida, 33428
Louise E. Morrell, 561-955-2141, LMorrell@brrh.com
Louise E. Morrell
- Recruiting
Steward Saint Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Beth B. Herrick, 617-789-3232, Beth.Herrick@steward.org
Beth B. Herrick
- Recruiting
Aultman Health Foundation
Canton, Ohio, 44710
Shruti Trehan, 330-363-2286, Shruti.trehan@aultman.com
Shruti Trehan
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Amie Hass, 319-398-6732, ahass@mercycare.org
Amie Hass
- Recruiting
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
Jennifer Van Horn, 307-996-1517, Jennifer.VanHorn@crmcwy.org
Jennifer Van Horn
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Pamela Ganschow, 312-864-4436, pganschow@cookcountyhhs.org
Pamela Ganschow
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Lydia Usha, 312-563-2200, Lydia_Usha@rush.edu
Lydia Usha
- Recruiting
John Muir Medical Center-Concord Campus
Concord, California, 94520
Shellie Campos, 925-947-3322, shellie.campos@johnmuirhealth.com
Shellie Campos
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Jeffrey N. Weitzel, 626-218-4334, jweitzel@coh.org
Jeffrey N. Weitzel
- Recruiting
Hunterdon Medical Center
Flemington, New Jersey, 08822
Kenneth B. Blankstein, 908-788-2566, kblankstein@hhpnj.org
Kenneth B. Blankstein
- Recruiting
Saint Agnes Hospital/Agnesian Cancer Center
Fond du Lac, Wisconsin, 54935
Michael W. Jones, 920-926-4100
Michael W. Jones
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Zdenka E. Segota, 954-267-7709, Ena.segota@holy-cross.com
Zdenka E. Segota
- Recruiting
Frederick Oncology Hematology Associates
Frederick, Maryland, 21702
Patricia A. Rice, 301-418-5010, price@fmh.org
Patricia A. Rice
- Recruiting
Saint Jude Medical Center
Fullerton, California, 92835
William E. Lawler, 714-446-5801, William.Lawlor@StJoe.org
William E. Lawler
- Not yet recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
April D. Sorrell, 713-798-6970
April D. Sorrell
- Recruiting
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Jeffrey N. Weitzel, 626-218-4334, jweitzel@coh.org
Jeffrey N. Weitzel
- Recruiting
Doctor's Hospital of Laredo
Laredo, Texas, 78041
Gary W. Unzeitig, 956-726-3691, drgwu@laredobreastcare.com
Gary W. Unzeitig
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Charite Ricker, 323-409-7710, Charite.Ricker@med.usc.edu
Charite Ricker
- Recruiting
Covenant Medical Center
Lubbock, Texas, 79410
Isaac Tafur, 806-725-7993, oncmd98@yahoo.com
Isaac Tafur
- Recruiting
Mount Kisco Medical Group at Northern Westchester Hospital
Mount Kisco, New York, 10549-3417
Nancy Cohen, 914-242-7649, NCohen@nwhc.net
Nancy Cohen
- Recruiting
Saint Joseph Hospital - Orange
Orange, California, 92868
Jeffrey N. Weitzel, 626-218-4334, jweitzel@coh.org
Jeffrey N. Weitzel
- Recruiting
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
Michael B. Dabrow, DabrowM@MLHS.ORG
Michael B. Dabrow
- Recruiting
Valleywise Comprehensive Health Center - Phoenix
Phoenix, Arizona, 85008
Ian K. Komenaka, 602-344-5368, Ian_Komenaka@dmgaz.org
Ian K. Komenaka
- Recruiting
Kootenai Cancer Center
Post Falls, Idaho, 83854
Jeffrey W. Allen, 208-625-4728, Mhander@kh.org
Jeffrey W. Allen
- Recruiting
Health Quest Medical Practice PC-Cardio Thoracic
Poughkeepsie, New York, 12601
Jonathan Clyman, 845-483-6279, jclyman@Health-quest.org
Jonathan Clyman
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661
Kristie A. Bobolis, 916-782-5106, bobolis@surewest.net
Kristie A. Bobolis
- Recruiting
Cancer Center of Santa Barbara
Santa Barbara, California, 93105
Frederic C. Kass, 805-563-5854, fkass@ccsb.org
Frederic C. Kass
- Recruiting
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Christopher R. Hake, 262-928-5539, chakemd@gmail.com
Christopher R. Hake
- Recruiting
Reading Hospital
West Reading, Pennsylvania, 19611
Terrence P. Cescon, 484-628-8000, CesconT@readinghospital.org
Terrence P. Cescon
Mexico3 sites, 3 recruiting
- Recruiting
University of Guadalajara
Guadalajara, Jalisco, CP 44340
Adrian Daneri-Navarro, 33 10585261 ext. 33871, Daneri@cucs.udg.mx
Adrian Daneri-Navarro
- Recruiting
Salvador Zubiran National Institute of Health Sciences and Nutrition
Mexico City, Tlalpan, 14080
Yanin Chavarri, 525554870900 ext. 2254, yanin.chavarrig@incmnsz.mx
Yanin Chavarri
- Recruiting
Monterrey Institute of Technology-TecSalud
Nuevo León
Cynthia Villarreal-Garza, 528183898395, cynthiavg@gmail.com
Cynthia Villarreal-Garza
Colombia2 sites, 2 recruiting
- Recruiting
Clinica del Country
Bogotá, Cundinamarca
Sandra X. Franco, 011 57 1 5300470, sfranco@clinicadelcountry.com
Sandra X. Franco
- Recruiting
Instituto de Cancerologia Las Americas
Medellín
Alicia M. Cock-Rada, 574 3409393, alicia@oncogenetica.co
Alicia M. Cock-Rada
Peru1 site, 1 recruiting
- Recruiting
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34
Julio E. Abugattas Saba, 51993579810, jabugattas@inen.sld.pe
Julio E. Abugattas Saba
Puerto Rico1 site, 1 recruiting
- Recruiting
University of Puerto Rico
San Juan, 00936
Marcia R. Cruz-Correa, 787-772-8300, marcia.cruz1@upr.edu
Marcia R. Cruz-Correa
About this study
This trial studies the genetic and behavioral factors that may contribute to the development of specific cancers and how these factors may affect the outcome of the disease in patients with a history of cancer and their relatives.
Read the detailed description
PRIMARY OBJECTIVES:
- To identify rare cancer patients and families in whom the pattern of disease suggests a genetic susceptibility to cancer or other etiology suggestive of a carcinogenic exposure and to characterize the underlying predisposition.
II. To determine the contribution of heredity (genotype) and biomarkers to clinical outcome (phenotype, occurrence of new cancers, prognosis and quality of life) in subgroups of cancer patients with and without clinical high-risk features.
OUTLINE:
Patients may provide a sample of blood, a saliva sample, a sample of eyebrow plucks, a sample of urine, and/or stored tumor or healthy tissue.
- Conditions
- Malignant Neoplasm
- Being tested
- Biospecimen Collection, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionOther
Provide a sample of blood, a saliva sample, a sample of eyebrow plucks, a sample of urine, and/or stored tumor or healthy tissue
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-correlative (biospecimen collection) | Participants may provide a sample of blood, a saliva sample, a sample of eyebrow plucks, a sample of urine, and/or stored tumor or healthy tissue. Receives: Other: Biospecimen Collection; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer risk assessment
Measured: Up to 10 years
Exploratory biomarkers for future studies
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start18 Apr 1997
- Primary completion18 Aug 2033 (estimated)
- Study completion18 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 999,999 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen Gruber, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185935
- Sponsor's protocol ID
- 96144
- Other IDs
- NCI-2019-05695, 96144
- Status last verified
- Jun 2026
- First submitted
- 3 Dec 2019
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Genetics Studies of Cancer Patients and Their Relatives
- ClinicalTrials.gov ID
- NCT04185935
- Acronym / sponsor ID
- 96144
- Conditions
- Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 999,999 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Apr 1997 (actual)
- Primary completion
- 18 Aug 2033 (estimated)
- Study completion
- 18 Aug 2033 (estimated)
- First posted
- 4 Dec 2019 (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.
This trial studies the genetic and behavioral factors that may contribute to the development of specific cancers and how these factors may affect the outcome of the disease in patients with a history of cancer and their relatives.
Detailed description
PRIMARY OBJECTIVES:
- To identify rare cancer patients and families in whom the pattern of disease suggests a genetic susceptibility to cancer or other etiology suggestive of a carcinogenic exposure and to characterize the underlying predisposition.
II. To determine the contribution of heredity (genotype) and biomarkers to clinical outcome (phenotype, occurrence of new cancers, prognosis and quality of life) in subgroups of cancer patients with and without clinical high-risk features.
OUTLINE:
Patients may provide a sample of blood, a saliva sample, a sample of eyebrow plucks, a sample of urine, and/or stored tumor or healthy tissue.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (biospecimen collection) | – | Other: Biospecimen Collection, Other: Questionnaire AdministrationParticipants may provide a sample of blood, a saliva sample, a sample of eyebrow plucks, a sample of urine, and/or stored tumor or healthy tissue. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with a family history of cancer
Key inclusion criteria (12 listed)
- Individuals must have a personal history of cancer and/or a family history of cancer suggestive of the presence of an inherited predisposition. This inherited predisposition might manifest as:
- Individuals may also be eligible by participation in the City of Hope Cancer Screening \& Prevention Program Network (CSPPN) clinical service or on the basis of membership in a group known or suspected to have an increased risk of carrying a genetic alteration or of sustaining a particular exposure that would place that at increased risk of cancer. (Examples would include members of occupational cohorts like asbestos workers, individuals with multiple dysplastic nevi in the absence of a family history of cancer, and individuals descended from a particular tribe in the American Southwest who have an increased incidence of a rare genetic alteration associated with an increased risk of a specific cancer.)
- Individuals and families may be referred to us in a number of different ways. After initial contact is made with a individual or family by family studies personnel; an individual within the bloodline will be identified as the historian. There may be more than one historian within a family
- At least one historian must be wiling to provide information or access as needed to contact appropriate family members for documentation of cancer and for consent. An individual is considered to be eligible to participate if they criteria; contact with relatives is not always indicated
- Individuals who are under 18 are eligible for study if they meet the criteria. Consent for participation must be given by a legal guardian or parent
Key exclusion criteria (1 listed)
- A family may be ineligible for study if the historian will not allow access to anyone within the family and thus, the accuracy of the family history cannot be established
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 |
|---|---|---|
| Biospecimen CollectionProvide a sample of blood, a saliva sample, a sample of eyebrow plucks, a sample of urine, and/or stored tumor or healthy tissue | Other | Ancillary-correlative (biospecimen collection) |
| Questionnaire AdministrationAncillary studies | Other | Ancillary-correlative (biospecimen collection) |
Primary outcome
Cancer risk assessment
Time frame: Up to 10 years
Exploratory biomarkers for future studies
Time frame: Up to 10 years
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 29 Jun 2026.
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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.
Stephen Gruber contact
Stephen Gruber, MD principal investigator
City of Hope Medical Center
42 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm, run by City of Hope Medical Center at 42 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Mexico, Colombia, Peru, Puerto Rico. 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 Stephen Gruber (sgruber@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer risk assessment (time frame: Up to 10 years). The study lists 2 primary outcomes in all. 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 29 Jun 2026.