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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-04008 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NRG-GY022 | Other Identifier | NRG Oncology | |
| NRG-GY022 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well iohexol works in helping doctors calculate the dose of carboplatin given to patients with cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Understanding how to best calculate the dose of carboplatin given to patients with cancer may help doctors learn how to improve the use of carboplatin in the future.
PRIMARY OBJECTIVES:
I. Evaluate the success of targeting a carboplatin area under the curve (AUC) with our current approach to dosing carboplatin.
II. Assess the performance of Cockcroft-Gault (CG), four-variable Modification of Diet in Renal Disease (MDRD-4), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) based on isotope dilution mass spectrometry (IDMS) calibrated serum creatinine in predicting measured glomerular filtration rate (mGFR) in patients with cancer.
III. Define the relationship of mGFR and carboplatin clearance in patients with cancer.
SECONDARY OBJECTIVES:
I. Evaluate the divergence of estimated (e)GFR from mGFR based on patient demographic and other characteristics, thus identifying those most likely to benefit from determination of mGFR over use of eGFR.
II. Determine the success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped.
III. Evaluate the relationship between carboplatin exposure and toxicity. IV. Assess the ability of markers other than creatinine in pre-treatment serum to better estimate kidney function in patients with cancer.
OUTLINE:
Patients receive iohexol intravenously (IV) over 30-60 seconds. Patients then receive standard of care carboplatin IV. Patients also undergo collection of 7-8 blood samples for analysis.
After completion of study, patients are followed up for 3-4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (iohexol, standard care carboplatin, blood samples) | Experimental | Patients receive iohexol IV over 30-60 seconds. Patients then receive standard of care carboplatin IV. Patients also undergo collection of 7-8 blood samples for analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of achieving the targeted carboplatin area under the curve (AUC) | Will be quantified by the median percentage error (PE), root-mean-squared error (RMSE), interquartile range (IQR) of the residuals, and median absolute percentage error (APE). In addition, the percentage of patients for which the observed carboplatin AUC is within 17% of target will be calculated. The actual AUC will be quantified using atomic absorption spectrophotometry. | Up to 4 weeks |
| Precision of achieving the targeted carboplatin AUC | Will be quantified by the median PE, RMSE, IQR of the residuals, and median APE. In addition, the percentage of patients for which the observed carboplatin AUC is within 17% of target will be calculated. The actual AUC will be quantified using atomic absorption spectrophotometry. | Up to 4 weeks |
| Bias of the formula for estimated glomerular filtration rate (eGFR) currently in existence in patients with cancer | Will be quantified by the median PE, RMSE, IQR of the residuals, and median APE will be used to assess the accuracy of each model's eGFR values for predicting measured (m)GFR. In addition, will calculate the percentage of patients for which eGFR is within 30%, 20%, and 10% of mGFR. | Up to 4 weeks |
| Precision of the formula for eGFR currently in existence in patients with cancer | Will be quantified by the median PE, RMSE, IQR of the residuals, and median APE will be used to assess the accuracy of each model's eGFR values for predicting mGFR. In addition, will calculate the percentage of patients for which eGFR is within 30%, 20%, and 10% of mGFR. | Up to 4 weeks |
| Correlation between carboplatin clearance (CL) and mGFR | Assessed by regression analysis. Carboplatin clearance will be derived by Empirical Bayes estimation using the POSTHOC option implemented in NONMEM. Will perform regression on the relationship between CL and mGFR. Initially this will follow a linear relationship analogous to the Calvert formula (CL = A + B* mGFR), and will test if the observed values for A and B are significantly different from those defined by Calvert as A = 25 mL/min and B = 1 (unitless). Will also perform regression by other means, e.g. after log transformation of the data, and assess if this results in a formula that performs better than the Calvert formula or the initial linear model. In addition, the impact of covariates on this relationship will be explored. |
| Measure | Description | Time Frame |
|---|---|---|
| Divergence of eGFR from mGFR | The bias of eGFR versus mGFR will be modeled as a function of the patient's characteristics. | Up to 4 weeks |
| Success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped |
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Inclusion Criteria:
Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
For men who are sexually active, the need for use of medically acceptable contraception will be dictated by the primary treatment plan/protocol
Male sex
Any patients who will receive treatment with intravenous carboplatin (any AUC, any cycle) on a National Cancer Institute (NCI)-sponsored National Clinical Trial Network (NCTN)-, Experimental Therapeutics Clinical Trials Network (ETCTN)-, trial, local trial, or through standard of care
Age >= 18
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah E Taylor | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center-Orange Grove Campus | Tucson | Arizona | 85704 | United States | ||
| Banner University Medical Center - Tucson |
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| Carboplatin | Drug | Given IV |
|
|
| Iohexol | Drug | Given IV |
|
|
| Up to 4 weeks |
Among patients with eGFR > 125 mL/min, precision and bias will be estimated relative to the target carboplatin AUC.
| Up to 4 weeks |
| Relationship between carboplatin exposure and toxicity | Will be described by the regression parameters for the estimated relationship between carboplatin AUC and platelet count, neutrophil count, and non-hematologic grade 3 toxicities. | Up to 4 weeks |
| Ability of markers in addition to creatinine in pre-treatment serum to better estimate kidney function in patients with cancer | These markers will include (but are not limited to) cystatin C, beta-2-microglobulin (B2M), and beta-trace-protein (BTP). Will use these markers and patient covariates (e.g. sex, race, weight etc.) as predictors for mGFR in regression efforts. | Up to 4 weeks |
| Tucson |
| Arizona |
| 85719 |
| United States |
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | United States |
| Mercy Hospital Fort Smith | Fort Smith | Arkansas | 72903 | United States |
| CARTI Cancer Center | Little Rock | Arkansas | 72205 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| UC San Diego Health System - Encinitas | Encinitas | California | 92024 | United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| UC San Diego Medical Center - Hillcrest | San Diego | California | 92103 | United States |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| Cancer Care and Hematology-Fort Collins | Fort Collins | Colorado | 80528 | United States |
| UCHealth Greeley Hospital | Greeley | Colorado | 80631 | United States |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | 83605 | United States |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | United States |
| Walter Knox Memorial Hospital | Emmett | Idaho | 83617 | United States |
| Idaho Urologic Institute-Meridian | Meridian | Idaho | 83642 | United States |
| Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho | 83687 | United States |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | 83854 | United States |
| Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Idaho | 83864 | United States |
| OSF Saint Anthony's Health Center | Alton | Illinois | 62002 | United States |
| Saint Mary's Hospital | Centralia | Illinois | 62801 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Carle at The Riverfront | Danville | Illinois | 61832 | United States |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | United States |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | United States |
| NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois | 60026 | United States |
| NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois | 60035 | United States |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | United States |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | United States |
| SSM Health Good Samaritan | Mount Vernon | Illinois | 62864 | United States |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | United States |
| Carle BroMenn Medical Center | Normal | Illinois | 61761 | United States |
| Carle Cancer Institute Normal | Normal | Illinois | 61761 | United States |
| University of Chicago Medicine-Orland Park | Orland Park | Illinois | 60462 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| The Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Reid Health | Richmond | Indiana | 47374 | United States |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | 50023 | United States |
| Saint Anthony Regional Hospital | Carroll | Iowa | 51401 | United States |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Iowa | 50325 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Iowa | 50309 | United States |
| Broadlawns Medical Center | Des Moines | Iowa | 50314 | United States |
| UI Health Care Mission Cancer and Blood - Laurel Clinic | Des Moines | Iowa | 50314 | United States |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| UI Healthcare Mission Cancer and Blood - Fort Dodge | Fort Dodge | Iowa | 50501 | United States |
| UI Health Care Mission Cancer and Blood - Waukee Clinic | Waukee | Iowa | 50263 | United States |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | United States |
| Central Care Cancer Center - Garden City | Garden City | Kansas | 67846 | United States |
| Central Care Cancer Center - Great Bend | Great Bend | Kansas | 67530 | United States |
| Mercy Hospital Pittsburg | Pittsburg | Kansas | 66762 | United States |
| Saint Elizabeth Healthcare Edgewood | Edgewood | Kentucky | 41017 | United States |
| Hematology/Oncology Clinic PLLC | Baton Rouge | Louisiana | 70809 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | United States |
| Mercy Oncology and Hematology - Clayton-Clarkson | Ballwin | Missouri | 63011 | United States |
| Central Care Cancer Center - Bolivar | Bolivar | Missouri | 65613 | United States |
| Cox Cancer Center Branson | Branson | Missouri | 65616 | United States |
| Mercy Cancer Center - Cape Girardeau | Cape Girardeau | Missouri | 63703 | United States |
| Freeman Health System | Joplin | Missouri | 64804 | United States |
| Mercy Hospital Joplin | Joplin | Missouri | 64804 | United States |
| Lake Regional Hospital | Osage Beach | Missouri | 65065 | United States |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | United States |
| Phelps Health Delbert Day Cancer Institute | Rolla | Missouri | 65401 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Mercy Infusion Center - Chippewa | St Louis | Missouri | 63109 | United States |
| Mercy Hospital South | St Louis | Missouri | 63128 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Mercy Hospital Washington | Washington | Missouri | 63090 | United States |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | United States |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | United States |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Great Falls Clinic | Great Falls | Montana | 59405 | United States |
| Hi-Line Sletten Cancer Center | Havre | Montana | 59501 | United States |
| Benefis Helena Specialty Center | Helena | Montana | 59601 | United States |
| Logan Health Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Center | Missoula | Montana | 59804 | United States |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89106 | United States |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| Clara Maass Medical Center | Belleville | New Jersey | 07109 | United States |
| Jefferson Cherry Hill Hospital | Cherry Hill | New Jersey | 08002 | United States |
| Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus | Elizabeth | New Jersey | 07207 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | United States |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Sidney Kimmel Cancer Center Washington Township | Sewell | New Jersey | 08080 | United States |
| Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | 08876 | United States |
| Community Medical Center | Toms River | New Jersey | 08755 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | United States |
| The Cancer Institute at Saint Francis Hospital | East Hills | New York | 11548 | United States |
| Arnot Ogden Medical Center/Falck Cancer Center | Elmira | New York | 14905 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Highland Hospital | Rochester | New York | 14620 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center-Weiler Hospital | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| Good Samaritan University Hospital | West Islip | New York | 11795 | United States |
| Indu and Raj Soin Medical Center | Beavercreek | Ohio | 45431 | United States |
| Saint Elizabeth Boardman Hospital | Boardman | Ohio | 44512 | United States |
| Dayton Physicians LLC-Miami Valley South | Centerville | Ohio | 45459 | United States |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | United States |
| University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | 45219 | United States |
| Oncology Hematology Care Inc-Kenwood | Cincinnati | Ohio | 45236 | United States |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Dayton Physician LLC - Englewood | Dayton | Ohio | 45415 | United States |
| Miami Valley Hospital North | Dayton | Ohio | 45415 | United States |
| Armes Family Cancer Center | Findlay | Ohio | 45840 | United States |
| Blanchard Valley Hospital | Findlay | Ohio | 45840 | United States |
| Orion Cancer Care | Findlay | Ohio | 45840 | United States |
| Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Dayton Physicians LLC-Atrium | Franklin | Ohio | 45005 | United States |
| Dayton Physicians LLC-Wayne | Greenville | Ohio | 45331 | United States |
| Miami Valley Cancer Care and Infusion | Greenville | Ohio | 45331 | United States |
| Wayne Hospital | Greenville | Ohio | 45331 | United States |
| Greater Dayton Cancer Center | Kettering | Ohio | 45409 | United States |
| First Dayton Cancer Care | Kettering | Ohio | 45420 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | United States |
| Springfield Regional Cancer Center | Springfield | Ohio | 45504 | United States |
| Springfield Regional Medical Center | Springfield | Ohio | 45504 | United States |
| Dayton Physicians LLC - Troy | Troy | Ohio | 45373 | United States |
| Upper Valley Medical Center | Troy | Ohio | 45373 | United States |
| Saint Joseph Warren Hospital | Warren | Ohio | 44484 | United States |
| University of Cincinnati Cancer Center-West Chester | West Chester | Ohio | 45069 | United States |
| Saint Elizabeth Youngstown Hospital | Youngstown | Ohio | 44501 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma | 73120 | United States |
| Saint Alphonsus Cancer Care Center-Baker City | Baker City | Oregon | 97814 | United States |
| Saint Alphonsus Cancer Care Center-Ontario | Ontario | Oregon | 97914 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | United States |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| Saint Joseph's/Candler - Bluffton Campus | Bluffton | South Carolina | 29910 | United States |
| Vanderbilt-Ingram Cancer Center at Franklin | Franklin | Tennessee | 37067 | United States |
| Vanderbilt-Ingram Cancer Center Cool Springs | Franklin | Tennessee | 37067 | United States |
| Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee | 37204 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| University of Utah Sugarhouse Health Center | Salt Lake City | Utah | 84106 | United States |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
| VCU Massey Cancer Center at Stony Point | Richmond | Virginia | 23235 | United States |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | United States |
| Monongalia Hospital | Morgantown | West Virginia | 26505 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Memorial Hospital of Laramie County | Cheyenne | Wyoming | 82001 | United States |
| Billings Clinic-Cody | Cody | Wyoming | 82414 | United States |
| Welch Cancer Center | Sheridan | Wyoming | 82801 | United States |
| Cancer Center-Metro Medical Center Bayamon | Bayamón | 00959-5060 | Puerto Rico |
| Puerto Rico Hematology Oncology Group | Bayamón | 00961 | Puerto Rico |
| HIMA San Pablo Oncologic Hospital | Caguas | 00726 | Puerto Rico |
| Doctors Cancer Center | Manati | 00674 | Puerto Rico |
| Instituto Oncologia Moderna Ponce | Ponce | 00716 | Puerto Rico |
| San Juan Community Oncology Group | San Juan | 00917 | Puerto Rico |
| Primary Care Physician Group | San Juan | 00920 | Puerto Rico |
| Centro Comprensivo de Cancer de UPR | San Juan | 00927 | Puerto Rico |
| PROncology | San Juan | 00927 | Puerto Rico |
| San Juan City Hospital | San Juan | 00936 | Puerto Rico |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D016190 | Carboplatin |
| D007472 | Iohexol |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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